PROG VALVE INLINE W SG
Report
- Report Number
- 3013886523-2024-00087
- Event Type
- Injury
- Date Received
- March 24, 2024
- Date of Event
- March 8, 2024
- Report Date
- May 2, 2024
- Manufacturer
- INTEGRA LIFESCIENCES MANSFIELD
- Product Code
- JXG
- UDI-DI
- 10381780519232
- PMA / PMN Number
- K041296
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE HAKIM VALVE (ID 823162) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) ¿ THE PRODUCT CODE 82-3162 WITH LOT 7298076, ONE REPORT WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE VALVE WAS VISUALLY INSPECTED: SOME BIOLOGICALS DEBRIS ON THE OUTSIDE OF THE HOUSING. THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 30MMH2O. THE VALVE PASSED THE TEST FOR PROGRAMMING, OCCLUSION, LEAK, REFLUX, SIPHON GUARD, AND PRESSURE. THE CATHETER WAS IRRIGATED, NO OCCLUSION NOTED. ROOT CAUSE ANALYSIS - NO ROOT CAUSE COULD BE DETERMINED FOR THE FAILURE ISSUE REPORTED BY THE CUSTOMER AS THE TECHNICIAN COULD NOT CONFIRM ANY PROBLEMS WITH THE VALVE AT THE TIME OF INVESTIGATION. A POSSIBLE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER COULD BE DUE TO BIOLOGICAL DEBRIS AND PROTEIN BUILD UP INTERFERING WITH THE DEVICE.
AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.
A PHYSICIAN REPORTED A HAKIM VALVE (ID 823162) PLACED ON (B)(6) 2024 WAS NOT FLOWING, THEREFORE IT WAS REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 460801 | PROG VALVE INLINE W SG | CHPV WITH SG | JXG | INTEGRA LIFESCIENCES MANSFIELD | 10381780519232 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |