BARD® URINE METER FOLEY CATHETER TRAY WITH BARDEX® LUBRICATH® FOLEY CA Adverse Event — Malfunction (MDR 1018233-2020-02858)
BARD® URINE METER FOLEY CATHETER TRAY WITH BARDEX® LUBRICATH® FOLEY CA Adverse Event — Malfunction (MDR 1018233-2020-02858) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: BARD® URINE METER FOLEY CATHETER TRAY WITH BARDEX® LUBRICATH® FOLEY CA; Generic name: FOLEY TRAY KIT; Manuf
| Device | BARD® URINE METER FOLEY CATHETER TRAY WITH BARDEX® LUBRICATH® FOLEY CA |
|---|---|
| Generic name | FOLEY TRAY KIT |
| Manufacturer | C.R. BARD, INC. (COVINGTON) -1018233 |
| Report number | 1018233-2020-02858 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | OTHER, USER FACILITY |
| Narrative | THE REPORTED EVENT COULD NOT BE CONFIRMED AS NO SAMPLE WAS RETURNED FOR EVALUATION. A POTENTIAL FAILURE MODE COULD BE ¿LEAKAGE¿ WITH A POTENTIAL ROOT CAUSE OF ¿TIP COVER CAME OFF DURING SHIPPING OR IN PROCESSING¿. 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: "BARD® EZ-LOK® SAMPLING PORT |
| Source | openFDA MAUDE (device adverse events) |
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