BD US CATHENA 20GX1.00IN STRAIGHT BC
Report
- Report Number
- 2243072-2024-01095
- Event Type
- Malfunction
- Date Received
- November 5, 2024
- Date of Event
- October 11, 2024
- Report Date
- November 27, 2024
- Manufacturer
- BECTON DICKINSON
- Product Code
- FOZ
- UDI-DI
- 00382903868629
- PMA / PMN Number
- K220584
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.
BASED ON DEVICE HISTORY RECORD REVIEW, NO ABNORMALITY WAS OBSERVED DURING THE PRODUCTION OF THE AFFECTED BATCH. AS CURRENT CONTROL, THERE ARE FUNCTIONAL TEST TO CHECK AND DETECT SAFETY ACTIVATION FAILURE. AS NO PHOTO AND SAMPLE IS RETURNED FOR EVALUATION, ROOT CAUSE COULD NOT BE ESTABLISHED.
IT WAS REPORTED THAT BD US CATHENA 20GX1.00IN STRAIGHT BC SAFETY SHIELD ACTIVATION FAILED (CATHETER) IT WAS REPORTED BY CUSTOMER THAT NURSE WAS INSERTING AN IV AND THE SAFETY LOCK DID NOT ENGAGE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED NURSE WAS INSERTING AN IV AND THE SAFETY LOCK DID NOT ENGAGE. ITEM -386862 LOT -4022034.
MATERIAL# 386862. BATCH# 4022034. IT WAS REPORTED BY CUSTOMER THAT NURSE WAS INSERTING AN IV AND THE SAFETY LOCK DID NOT ENGAGE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. NURSE WAS INSERTING AN IV AND THE SAFETY LOCK DID NOT ENGAGE. ITEM -386862. LOT -4022034.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 71557 | BD US CATHENA 20GX1.00IN STRAIGHT BC | INTRAVASCULAR CATHETER | FOZ | BECTON DICKINSON | 4022034 | 00382903868629 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |