BD INSYTE AUTOGUARD
Report
- Report Number
- 1710034-2025-00398
- Event Type
- Malfunction
- Date Received
- March 13, 2025
- Date of Event
- February 14, 2025
- Report Date
- April 4, 2025
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
- Product Code
- FOZ
- UDI-DI
- 00382903818235
- PMA / PMN Number
- K201075
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PE
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INITIAL REPORTER INFORMATION UPDATED IN E TAB.
H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. B3. 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 381823 AND LOT NUMBER 3032974. 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.
NO ADDITIONAL INFORMATION.
IT WAS REPORTED THAT BD INSYTE AUTOGUARD CATHETER TIP WAS BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: 1. WHEN CANNULATING THE PATIENT, THE DISTAL TIP WAS BROKEN, WHICH PREVENTED THE PASSAGE OF THE NEEDLE, AND AT THE TIME OF REMOVAL, THE PATIENT REPORTED A LOT OF PAIN.
NO ADDITIONAL INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1254011 | BD INSYTE AUTOGUARD | PERIPHERAL IV CATHETERS | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. | 3032974 | 00382903818235 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |