ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER Adverse Event — Malfunction (MDR 1820334-2020-00870)
ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER Adverse Event — Malfunction (MDR 1820334-2020-00870) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER; Generic name: FGE CATHETER, BILIARY, DIAGNOSTIC; Manufacturer
| Device | ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER |
|---|---|
| Generic name | FGE CATHETER, BILIARY, DIAGNOSTIC |
| Manufacturer | COOK INC |
| Report number | 1820334-2020-00870 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | FOREIGN, OTHER, USER FACILITY |
| Narrative | H6 ¿ ADDITIONAL METHOD CODE: DEVICE NOT RETURNED (4114). INVESTIGATION ¿ EVALUATION: A REPORT FROM A COMPETENT AUTHORITY WAS RECEIVED REGARDING AN INCIDENT AT (B)(6) HOSPITAL INVOLVING A ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER. THE DAY AFTER PLACEMENT, THE HUB OF THE CATHETER WAS FOUND TO BE SEPARATED. THE CATHETER WAS REMOVED FROM THE PATIENT. THE PATIENT REFUSED TO HAVE A NEW C |
| Source | openFDA MAUDE (device adverse events) |
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