BD INSYTE AUTOGUARD
Report
- Report Number
- 1710034-2024-00002
- Event Type
- Malfunction
- Date Received
- January 5, 2024
- Date of Event
- December 7, 2023
- Report Date
- July 25, 2024
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
- Product Code
- FOZ
- UDI-DI
- 00382903814343
- PMA / PMN Number
- K201075
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- 505
Narratives
H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION A SUPPLEMENTAL REPORT WILL BE FILED. THE PROVIDED LOT NUMBER WAS NOT FOUND.
LOT NUMBER 3241126 WAS PROVIDED BY CUSTOMER BUT WAS NOT INITIALLY ADDED TO THE MATERIAL GRID.
NO PHOTOGRAPHIC EVIDENCE OR PHYSICAL SAMPLES WERE ACCESSIBLE TO INVESTIGATE THE REPORTED CONDITION. OUR QUALITY ENGINEER TEAM CONDUCTED A COMPREHENSIVE REVIEW OF THE DEVICE HISTORY RECORD FOR THE PROVIDED MATERIAL NUMBER: 381434 AND LOT NUMBER: 3241126. THIS REVIEW DID NOT UNCOVER ANY ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CAUSED THIS DEFECT, AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN THE SPECIFIED STANDARDS. UNFORTUNATELY, THE EXACT CAUSE OF THIS INCIDENT COULD NOT BE DETERMINED BASED ON THE INFORMATION AVAILABLE.
IT WAS REPORTED THAT BD INSYTE AUTOGUARD HAS PLASTIC ON THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE ARE CURRENTLY HAVING ISSUES WITH BD INSYTE 20GA. WHEN THE NURSE REMOVES CAP, OCCASIONALLY A SMALL PIECE OF PLASTIC IS SITTING ON THE NEEDLE.
NA.
NO ADDITIONAL INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 674898 | BD INSYTE AUTOGUARD | PERIPHERAL IV CATHETERS | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. | 3241126 | 00382903814343 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |