BARDEX® LUBRICATH® FOLEY CATHETER CREEVY MODEL Adverse Event — Malfunction (MDR 1018233-2020-02837)
BARDEX® LUBRICATH® FOLEY CATHETER CREEVY MODEL Adverse Event — Malfunction (MDR 1018233-2020-02837) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: BARDEX® LUBRICATH® FOLEY CATHETER CREEVY MODEL; Generic name: CONT. IRRIGATION CATHETER; Manufacturer: C.R. BARD, INC. (COVINGTON)
| Device | BARDEX® LUBRICATH® FOLEY CATHETER CREEVY MODEL |
|---|---|
| Generic name | CONT. IRRIGATION CATHETER |
| Manufacturer | C.R. BARD, INC. (COVINGTON) -1018233 |
| Report number | 1018233-2020-02837 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, OTHER |
| Narrative | THE REPORTED EVENT WAS CONFIRMED, AS MANUFACTURING-RELATED. THE AMBER LUBRICATH 75CC IRRIGATION FOLEY CATHETER WITH AT9268 DATE CODE WAS INFLATED WITH 80CC OF WATER AND NO LEAKS WERE NOTED. THE BALLOON WAS THEN PASSIVELY DEFLATED. WATER WAS FOUND TO REMAIN IN THE BALLOON AFTER DEFLATION. THIS DID NOT MEET SPECIFICATIONS. THE DEVICE APPEARED TO BE USED FOR TREATMENT. AS THE BALLOON DID NOT FULLY DE |
| Source | openFDA MAUDE (device adverse events) |
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