BD US CATHENA 20GX1.00IN STRAIGHT BC
Report
- Report Number
- 2243072-2024-01293
- Event Type
- Malfunction
- Date Received
- January 6, 2025
- Date of Event
- December 16, 2024
- Report Date
- January 15, 2025
- Manufacturer
- BECTON DICKINSON
- Product Code
- FOZ
- UDI-DI
- 00382903868629
- PMA / PMN Number
- K220584
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.
OUR QUALITY ENGINEER INSPECTED THE PHOTO SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF SAFETY SHIELD ACTIVATION FAILURE WAS CONFIRMED UPON INSPECTION OF THE PHOTO. HOWEVER, BD CANNOT CONFIRM THE CAUSE OF THE FAILURE TO OUR MANUFACTURING PROCESS SINCE NO PHYSICAL SAMPLE WAS RETURNED. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY. PRODUCTION RECORDS WERE REVIEWED, AND THIS BATCH MEETS OUR MANUFACTURING SPECIFICATION REQUIREMENTS.
IT WAS REPORTED THAT BD US CATHENA 20GX1.00IN STRAIGHT BC SAFETY SHIELD ACTIVATION FAILED IT WAS REPORTED BY CUSTOMER THAT THE SAFETY DID NOT SLIP OVER NEEDLE. VERBATIM: SAFETY DID NOT SLIP OVER NEEDLE.
MATERIAL # 386862. BATCH # 4160445. IT WAS REPORTED BY CUSTOMER THAT THE SAFETY DID NOT SLIP OVER NEEDLE. VERBATIM: SAFETY DID NOT SLIP OVER NEEDLE. RESPONSE ON DECEMBER 30, 2024. CUSTOMER CONFIRMED THAT PRODUCT SAMPLE IS NOT AVAILABLE. IT WAS DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 351648 | BD US CATHENA 20GX1.00IN STRAIGHT BC | INTRAVASCULAR CATHETER | FOZ | BECTON DICKINSON | 4160445 | 00382903868629 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |