BD INSYTE AUTOG BC WING
Report
- Report Number
- 1710034-2024-01239
- Event Type
- Malfunction
- Date Received
- October 30, 2024
- Date of Event
- October 8, 2024
- Report Date
- November 19, 2024
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
- Product Code
- FOZ
- UDI-DI
- 00382903826339
- PMA / PMN Number
- K201075
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- 003
Narratives
A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.
INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 382623 AND LOT NUMBER 4222721. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED.
IT WAS REPORTED THAT BD INSYTE AUTOG BC WING CATHETER TIP IS BREAKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: COMPLAINTS - RECEIVED VIA CHAT WE HAVE BEEN HAVING ISSUES WITH INSYTE AUTOGUARD BC WINGED CATHETERS. THEY ARE BENDING AND THE TIPS ARE BREAKING. ITEMS 382633 AND 382623, LOT 4222721 AND 4177943 ,CUSTOMER ADVISED THEY WILL LET MY CLINICAL COORDINATOR DISCUSS IN ARE THE DETAILS WITH BD REP. SERIOUS INJURY: NO. DEATH: NO.
NO ADDITIONAL INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1804301 | BD INSYTE AUTOG BC WING | PERIPHERAL IV CATHETERS | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. | 4222721 | 00382903826339 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |