BD NEXIVA 22 GA X 1 IN SINGLE PORT
Report
- Report Number
- 2243072-2024-01256
- Event Type
- Malfunction
- Date Received
- December 24, 2024
- Date of Event
- December 2, 2024
- Report Date
- May 8, 2025
- Manufacturer
- BECTON DICKINSON
- Product Code
- FOZ
- PMA / PMN Number
- K183399
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.
OUR QUALITY ENGINEER INSPECTED THE PHOTOS SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF LABEL CONTENT MISSING WAS CONFIRMED UPON INSPECTION OF THE PHOTOS. THE ROOT CAUSE IS THE PRODUCTION TECHNICIAN PICKING THE REJECTED PARTS FROM THE AUTO-CARTONER AND PACKING THEM INTO THE DISPENSER BOX AS GOOD PARTS. ACTION WAS TAKEN TO COMMUNICATE THIS DEFECT TO ALL PRODUCTION TECHNICIANS TO SCRAP ALL REJECTED PARTS FROM THE AUTO- CARTONER AND NOT USING THEM TO FILL UP THE DISPENSER. THE REPORTED LOT WAS MANUFACTURED BEFORE ACTION TAKEN. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY. PRODUCTION RECORDS WERE REVIEWED, AND THIS BATCH MEETS OUR MANUFACTURING SPECIFICATION REQUIREMENTS.
BECTON DICKINSON AND COMPANY'S (BD) MEDICATION DELIVERY SOLUTIONS (MDS) BUSINESS UNIT WILL DISCONTINUE MALFUNCTION MDR REPORTING FOR CERTAIN DEVICE FAILURES THAT HAVE NOT CAUSED OR CONTRIBUTED TO DEATHS OR SERIOUS INJURIES IN THE PAST TWO YEARS, AND WHERE THE LIKELIHOOD OF A DEATH OR SERIOUS INJURY AS A RESULT OF THESE MALFUNCTIONS IS REMOTE. THIS DECISION FOLLOWS FDA GUIDELINES (MEDICAL DEVICE REPORTING FOR MANUFACTURERS GUIDANCE FOR INDUSTRY AND FOOD AND DRUG ADMINISTRATION STAFF ISSUED NOV 8, 2016, REFERENCE SECTION 2.15). BD NOTIFIED FDA OF THIS DECISION ON MAR 3, 2025. FDA HAS REVIEWED AND RESPONDED TO BDS NOTIFICATION (REFERENCE FDA DOCUMENT # (B)(4)) ON MARCH 7, 2025. THIS DOCUMENTATION IS AVAILABLE IN BD DOCUMENT MANAGEMENT SYSTEM (SAP) AS DIR (B)(4). THIS SUPPLEMENTAL MDR IS BEING FILED TO DOCUMENT THAT THE BELOW DEVICE FAILURE WILL NO LONGER BE CONSIDERED A REPORTABLE MALFUNCTION MDR FOR THE PRODUCT FAMILY BELOW: PRODUCT FAMILY: NEXIVA. DEVICE FAILURE: LABELING CONCERNS.
IT WAS REPORTED THAT BD NEXIVA 22 GA X 1 IN SINGLE PORT LABEL CONTENT MISSING IT WAS REPORTED THAT WHILE SORTING THIS PRODUCT WITHIN THE HOSPITAL, IT WAS DISCOVERED THAT THREE INDIVIDUALLY WRAPPED TYVEK PRODUCTS NOT PRINTED ON THE PACKAGING HAD BEEN MIXED IN.
IT WAS REPORTED THAT WHILE SORTING THIS PRODUCT WITHIN THE HOSPITAL, IT WAS DISCOVERED THAT THREE INDIVIDUALLY WRAPPED TYVEK PRODUCTS NOT PRINTED ON THE PACKAGING HAD BEEN MIXED IN.
NO ADDITIONAL INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2365625 | BD NEXIVA 22 GA X 1 IN SINGLE PORT | INTRAVASCULAR CATHETER | FOZ | BECTON DICKINSON | 4127395 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |