FDA Adverse Event
Malfunction
Summary report: N
ZERO TIP
MDR report key: 17808993
·
Received September 25, 2023
Report
- Report Number
- 3005099803-2023-05152
- Event Type
- Malfunction
- Date Received
- September 25, 2023
- Date of Event
- September 1, 2023
- Report Date
- September 25, 2023
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FFL
- UDI-DI
- 08714729469643
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHARMACIST
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK H6: IMDRF DEVICE CODE A020504 CAPTURES THE REPORTABLE EVENT OF PACKAGING TEAR, RIP OR HOLE.
Description of Event or Problem · 0
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ZERO TIP BASKET WAS USED IN AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2023. IT WAS REPORTED THAT WHEN THE PACKAGE WAS OPENED, THEY NOTICED THAT THE BACK OF THE PACKAGING WAS CRACKED RESULTING IN BREAKAGE IF THE DEVICE STERILITY. THE PROCEDURE WAS COMPLETED WITH ANOTHER ZERO TIP BASKET. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1421816 | ZERO TIP | DISLODGER, STONE, BASKET, URETERAL, METAL | FFL | BOSTON SCIENTIFIC CORPORATION | M0063901050 | 0029167774 | 08714729469643 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |