NEXIVA
Report
- Report Number
- 1710034-2026-00514
- Event Type
- Malfunction
- Date Received
- May 15, 2026
- Date of Event
- April 28, 2026
- Report Date
- May 19, 2026
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
- Product Code
- FOZ
- UDI-DI
- 00382903835195
- PMA / PMN Number
- SEE H.11
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
E.1. CHARACTERS LIMIT IS EXCEEDED AT FACILITY NAME: (B)(6). G.4. K183399; K243403. H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.
INVESTIGATION SUMMARY: THE REPORTED DEFECT COULD NOT BE REFUTED NOR CONFIRMED IN THE ABSENCE OF A SAMPLE. THE ROOT CAUSE CANNOT BE DETERMINED FOR AN UNCONFIRMED DEFECT. A COMPLAINT HISTORY CHECK WAS PERFORMED, AND THIS IS THE 2ND RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF LEAKAGE AT CATHETER JUNCTION WITH LOT 5170562 REGARDING ITEM 383519. DEVICE HISTORY RECORD FOR LOT 5170562 HAS BEEN REVIEWED. NO RELATED QUALITY ISSUES OR PROCESS DEVIATIONS WERE FOUND. A REVIEW OF THE APPLICABLE RISK DOCUMENTS INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY IN THE RISK MANAGEMENT DOCUMENTATION.
IT WAS REPORTED THAT NEXIVA LEAKED. WHEN IN USE, THE CLEAR CANNULA HUB LEAKS WHERE IT CONNECTS TO THE CATHETER, DEFECTIVE QUANTITY 1.
NO ADDITIONAL INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 525613 | NEXIVA | PERIPHERAL IV CATHETERS | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. | 5170562 | 00382903835195 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |