FDA Adverse Event
Malfunction
Summary report: N
CODMAN BEVD 1.9MM CAT SET
MDR report key: 24781391
·
Received April 3, 2026
Report
- Report Number
- 3013886523-2026-00077
- Event Type
- Malfunction
- Date Received
- April 3, 2026
- Report Date
- May 15, 2026
- Manufacturer
- INTEGRA LIFESCIENCES MANSFIELD
- Product Code
- JXG
- UDI-DI
- 10381780518440
- PMA / PMN Number
- K233448
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 0
A FACILITY REPORTED AN EXPIRED BACTISEAL CATHETER (ID: 821749) WAS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER SEVERAL ATTEMPTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 63322 | CODMAN BEVD 1.9MM CAT SET | BACTISEAL | JXG | INTEGRA LIFESCIENCES MANSFIELD | 7511955 | 10381780518440 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |