200CC CLOSED WOUND SUCTION SILICONE EVACUATOR FOR USE WITH ALL BARD CL Adverse Event — Malfunction (MDR 1018233-2020-02855)
200CC CLOSED WOUND SUCTION SILICONE EVACUATOR FOR USE WITH ALL BARD CL Adverse Event — Malfunction (MDR 1018233-2020-02855) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: 200CC CLOSED WOUND SUCTION SILICONE EVACUATOR FOR USE WITH ALL BARD CL; Generic name: SUCTION EVACUATOR; Ma
| Device | 200CC CLOSED WOUND SUCTION SILICONE EVACUATOR FOR USE WITH ALL BARD CL |
|---|---|
| Generic name | SUCTION EVACUATOR |
| Manufacturer | C.R. BARD, INC. (COVINGTON) -1018233 |
| Report number | 1018233-2020-02855 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | DISTRIBUTOR, OTHER |
| Narrative | THE REPORTED EVENT WAS UNCONFIRMED SINCE THE REPORTED FAILURE COULD NOT BE REPRODUCED. VISUAL EVALUATION OF THE RETURNED SAMPLE NOTED ONE OPENED (NO ORIGINAL PACKAGING PRESENT), 200CC SILICONE BULB EVACUATOR WITH CLAMP. VISUAL INSPECTION OF THE SAMPLE NOTED NO OBVIOUS VISIBLE DEFECTS. THE INLET VALVE WAS CLOSED TIGHTLY AND THE BULB BODY WAS DEPRESSED. NEGATIVE PRESSURE WAS CREATED AND THE BULB WAS |
| Source | openFDA MAUDE (device adverse events) |
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