FDA Adverse Event
Malfunction
Summary report: N
PERCUFLEX URINARY DIVERSION STENT SET
MDR report key: 17660668
·
Received August 31, 2023
Report
- Report Number
- 3005099803-2023-04555
- Event Type
- Malfunction
- Date Received
- August 31, 2023
- Date of Event
- August 7, 2023
- Report Date
- August 31, 2023
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LJE
- UDI-DI
- 08714729297185
- PMA / PMN Number
- K830803
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BLOCK H6: IMDRF DEVICE CODE A020513- CAPTURES THE REPORTABLE EVENT OF PACKAGING SEAL COMPROMISED.
Description of Event or Problem · 0
IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN PERCUFLEX URINARY DIVERSION STENT SET WAS RECEIVED ON AUGUST 07, 2023. IT WAS FOUND THAT THE STENT ARRIVED IN THE FACILITY DAMAGED. IT WAS OBSERVED THAT THE PACKAGING WAS SOMEHOW AFFECTED BY HEAT. THE STERILE BARRIER WAS COMPROMISED. THERE WAS NO PATIENT INVOLVEMENT, AND THIS DEVICE WAS NOT USED IN A PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1390046 | PERCUFLEX URINARY DIVERSION STENT SET | CATHETER, NEPHROSTOMY | LJE | BOSTON SCIENTIFIC CORPORATION | M0061602150 | 0031497488 | 08714729297185 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |