FDA Adverse Event
Malfunction
Summary report: N
JP CHANNEL DRAIN SILICONE HUBLESS 15FR
MDR report key: 14538704
·
Received May 29, 2022
Report
- Report Number
- 8030107-2022-00003
- Event Type
- Malfunction
- Date Received
- May 29, 2022
- Date of Event
- February 1, 2022
- Report Date
- May 29, 2022
- Manufacturer
- DEGANIA SILICONE LTD
- Product Code
- OTK
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
THERE WERE NO NON-CONFORMITIES DETECTED DURING THE BATCH HISTORY REVIEW AND TESTING OF THE RETAIN SAMPLE. THE DRAIN COULD TEAR DUE TO SOME DAMAGE IN USE. THE COMPLAINT CONSIDERED TO BE NOT JUSTIFIED; NO CAPA WILL BE REQUIRED IN THIS CASE.
Description of Event or Problem · 0
DRAIN FRACTURED UPON REMOVAL ON DAY OF PLANNED DISCHARGE. PATIENT RETURNED TO OPERATING ROOM ON SAME DAY TO TAKE OUT REMNANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1878455 | JP CHANNEL DRAIN SILICONE HUBLESS 15FR | JP CHANNEL DRAIN SILICONE HUBLESS 15FR | OTK | DEGANIA SILICONE LTD | 15FR | P2100072 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |