INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC
Report
- Report Number
- 3006948883-2025-00688
- Event Type
- Malfunction
- Date Received
- September 16, 2025
- Date of Event
- June 20, 2025
- Report Date
- October 28, 2025
- Manufacturer
- BECTON DICKINSON
- Product Code
- FOZ
- PMA / PMN Number
- UNK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INVESTIGATION RESULTS: NO ABNORMALITY IS FOUND ON PROCESS AND RETAINED SAMPLE, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS ABOUT THIS BATCH OF PRODUCTS. AS THE DEFECTIVE SAMPLE WAS NOT RETURNED AND ITS USAGE CONDITIONS ARE UNKNOWN, RELEVANT TESTING COULD NOT BE CONDUCTED, SO THE ROOT CAUSE OF THE COMPLAINT DEFECT CANNOT BE DETERMINED. THIS COMPLAINT IS AN ISOLATED CASE, AND THE PLANT WILL CONTINUE TO TRACK THIS ISSUE.
H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.
NO ADDITIONAL INFORMATION.
IT WAS REPORTED THAT BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPV - NEEDLE BROKEN. ON (B)(6) 2025, AT 9:00 AM, WHILE PERFORMING AN IV CANNULATION WITH AN INDWELLING NEEDLE, THE NURSE ENCOUNTERED A FRACTURE AT THE FIN-SHAPED NEEDLE HUB DURING NEEDLE WITHDRAWAL, RENDERING THE FRONT NEEDLE SEGMENT INEXTRICABLE. THE NEEDLE WAS IMMEDIATELY REMOVED, AND THE IV CANNULATION WAS PERFORMED AGAIN AFTER REPLACING THE INDWELLING NEEDLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2650568 | INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC | INTRAVASCULAR CATHETER | FOZ | BECTON DICKINSON | 4198427 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |