FDA Adverse Event
Malfunction
Summary report: N
NEXIVA
MDR report key: 25113473
·
Received May 7, 2026
Report
- Report Number
- 2243072-2026-00353
- Event Type
- Malfunction
- Date Received
- May 7, 2026
- Date of Event
- April 9, 2026
- Report Date
- April 27, 2026
- Manufacturer
- BECTON DICKINSON
- Product Code
- FOZ
- UDI-DI
- 00382903835119
- PMA / PMN Number
- K183399
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem · 0
IT WAS REPORTED BY CUSTOMER THAT THEY DEAL WITH ITEMS BREAKING UPON USE AND PATIENT DISCOMFORT VERBATIM: COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. WE HAVE RECEIVED THE BELOW QUALITY COMPLAINT FROM OUR END USER AND THEY HAVE PULLED THE PRODUCT FROM THEIR SHELVES. PLEASE PROVIDE A RETURN AUTHORIZATION/ SHIPPING LABELS FOR THE BELOW PRODUCT. (B)(6) ITEM NUMBER 383511 QTY/UM - (B)(4) EA LOT NUMBER - 5297500 ISSUE - CUSTOMER HAS DEALT WITH ITEMS BREAKING UPON USE AND PATIENT DISCOMFORT
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 467884 | NEXIVA | INTRAVASCULAR CATHETER | FOZ | BECTON DICKINSON | 5297500 | 00382903835119 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |