BARDEX® ALL-SILICONE FOLEY CATHETER Adverse Event — Malfunction (MDR 1018233-2020-02856)
BARDEX® ALL-SILICONE FOLEY CATHETER Adverse Event — Malfunction (MDR 1018233-2020-02856) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: BARDEX® ALL-SILICONE FOLEY CATHETER; Generic name: FOLEY CATHETER (SILICONE); Manufacturer: C.R. BARD, INC. (COVINGTON) -1018233.
| Device | BARDEX® ALL-SILICONE FOLEY CATHETER |
|---|---|
| Generic name | FOLEY CATHETER (SILICONE) |
| Manufacturer | C.R. BARD, INC. (COVINGTON) -1018233 |
| Report number | 1018233-2020-02856 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | HEALTH PROFESSIONAL, OTHER |
| Narrative | THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION NOTED ONE TWO-WAY FOLEY CATHETER WAS RECEIVED. VISUAL EVALUATION NOTED NO OBVIOUS DEFECTS. IT WAS ATTEMPTED TO INFLATE THE BALLOON WITH A METHYLENE BLUE AND WATER SOLUTION AND IT IMMEDIATELY LEAKED FROM A PINHOLE MEASURING 0.019" IN THE BALLOON SURFACE. NO MISSING PIECES WERE NOTED. THIS IS A FAILURE PER INSPECTION PROCEDURE WHICH STATES THAT PIN |
| Source | openFDA MAUDE (device adverse events) |
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