BARDEX FOLEY CATHETER SILICONE COATED Adverse Event — Malfunction (MDR 1018233-2020-02912)
BARDEX FOLEY CATHETER SILICONE COATED Adverse Event — Malfunction (MDR 1018233-2020-02912) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: BARDEX FOLEY CATHETER SILICONE COATED; Generic name: BARDIA FOLEY CATHETER; Manufacturer: C.R. BARD, INC. (COVINGTON) -1018233.
| Device | BARDEX FOLEY CATHETER SILICONE COATED |
|---|---|
| Generic name | BARDIA FOLEY CATHETER |
| Manufacturer | C.R. BARD, INC. (COVINGTON) -1018233 |
| Report number | 1018233-2020-02912 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, OTHER |
| Narrative | THE REPORTED EVENT WAS INCONCLUSIVE AS NO SAMPLE WAS RETURNED FOR EVALUATION. A POTENTIAL ROOT CAUSE FOR THIS FAILURE MODE COULD BE USER RELATED (EXAMPLE: CONTACT WITH SHARP OBJECT)/MECHANICAL FAILURE/OPERATOR ERROR/THIN RUBBERIZE LAYER). THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUAT |
| Source | openFDA MAUDE (device adverse events) |
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