FDA Adverse Event
Malfunction
Summary report: N
NEXIVA 20GA 1.75IN HF Y
MDR report key: 18506339
·
Received January 12, 2024
Report
- Report Number
- 1710034-2024-00009
- Event Type
- Malfunction
- Date Received
- January 12, 2024
- Date of Event
- December 26, 2023
- Report Date
- February 29, 2024
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
- Product Code
- FOZ
- UDI-DI
- 30382903835387
- PMA / PMN Number
- K102520
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
Additional Manufacturer Narrative · 0
INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCE'S ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED.
Description of Event or Problem · 0
IT WAS REPORTED BD NEXIVA 20GA 1.75IN HF Y LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BLOOD LEAKING FROM CONNECTION OF HUB AND STABILIZATION WINGS IMMEDIATELY AFTER INSERTION."
Description of Event or Problem · 0
NO ADDITIONAL INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1827774 | NEXIVA 20GA 1.75IN HF Y | PERIPHERAL IV CATHETERS | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. | 3241214 | 30382903835387 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |