FDA Adverse Event
Malfunction
Summary report: N
BD US CATHENA 20GX1.00IN STRAIGHT BC
MDR report key: 22032521
·
Received May 15, 2025
Report
- Report Number
- 2243072-2025-00653
- Event Type
- Malfunction
- Date Received
- May 15, 2025
- Date of Event
- April 25, 2025
- Report Date
- June 23, 2025
- Manufacturer
- BECTON DICKINSON
- Product Code
- FOZ
- UDI-DI
- 00382903868629
- PMA / PMN Number
- K220584
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
D.3. FRANKLIN LAKES HAS BEEN LISTED AS THE MANUFACTURER. G.1. FRANKLIN LAKES HAS BEEN LISTED AS THE MANUFACTURER. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.
Additional Manufacturer Narrative · 0
NO PHOTO/SAMPLE RECEIVED FOR INVESTIGATION.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE BD US CATHENA 20GX1.00IN STRAIGHT BC HAD BLOOD LEAKAGE OUT OF THE CONTROL PLUG. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #:386862; BATCH#:4265921. VERBATIM: FAILED BLOOD CONTROL VALVE. ADDITIONAL INFORMATION PROVIDED: HI, WE HAVE NOW HAD 3 INCIDENTS WITH LOT NUMBER 4265921. THE ONLY NEGATIVE OUTCOME WAS THE POTENTIAL FOR BBP EXPOSURE FOR THE CAREGIVERS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1215944 | BD US CATHENA 20GX1.00IN STRAIGHT BC | INTRAVASCULAR CATHETER | FOZ | BECTON DICKINSON | 4265921 | 00382903868629 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |