BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER Adverse Event — Malfunction (MDR 1018233-2020-02871)
BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER Adverse Event — Malfunction (MDR 1018233-2020-02871) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER; Generic name: LUBRISIL CATHETER; Manufacturer: C.R. BARD, INC. (COVINGTON) -1018233
| Device | BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER |
|---|---|
| Generic name | LUBRISIL CATHETER |
| Manufacturer | C.R. BARD, INC. (COVINGTON) -1018233 |
| Report number | 1018233-2020-02871 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, HEALTH |
| Narrative | THE REPORTED EVENT COULD NOT BE CONFIRMED AS NO SAMPLE WAS RETURNED FOR EVALUATION. A POTENTIAL FAILURE MODE COULD BE ¿BALLOON COLLAPSES¿ WITH A POTENTIAL ROOT CAUSE OF " INFLATION / DRAINAGE LUMEN WALL PERFORATED". THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "VALVE TYPE: USE LUER SLIP |
| Source | openFDA MAUDE (device adverse events) |
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