BD NEXIVA¿ CLOSED IV CATHETER SYSTEM - DUAL PORT 24 GA 0.75 IN
Report
- Report Number
- 1710034-2022-00002
- Event Type
- Malfunction
- Date Received
- January 14, 2022
- Date of Event
- December 22, 2021
- Report Date
- January 18, 2022
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
- Product Code
- FOZ
- UDI-DI
- 30382903835318
- PMA / PMN Number
- K183399
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1155068. MEDICAL DEVICE EXPIRATION DATE: 2024-05-31. DEVICE MANUFACTURE DATE: 2021-06-04. MEDICAL DEVICE LOT #: 1091027. MEDICAL DEVICE EXPIRATION DATE: 2024-03-31. DEVICE MANUFACTURE DATE: 2021-04-01. MEDICAL DEVICE LOT #: 1091940. MEDICAL DEVICE EXPIRATION DATE: 2024-03-31. DEVICE MANUFACTURE DATE: 2021-04-01.
A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1155068. MEDICAL DEVICE EXPIRATION DATE: 2024-05-31. DEVICE MANUFACTURE DATE: 2021-06-04. MEDICAL DEVICE LOT #: 1091027. MEDICAL DEVICE EXPIRATION DATE: 2024-03-31. DEVICE MANUFACTURE DATE: 2021-04-01. MEDICAL DEVICE LOT #: 1091940. MEDICAL DEVICE EXPIRATION DATE: 2024-03-31. DEVICE MANUFACTURE DATE: 2021-04-01.
H6: INVESTIGATION SUMMARY OUR QUALITY ENGINEER INSPECTED THE SAMPLES AND PHOTOGRAPHS SUBMITTED FOR EVALUATION. BD RECEIVED FIFTEEN SEALED UNITS AND TEN PHOTOS. UPON VISUAL INSPECTION, ELEVEN OF THE UNITS WERE FOUND TO HAVE FOREIGN MATERIAL. THE REPORTED DEFECT WAS CONFIRMED. ONE UNIT WAS FOUND TO HAVE FOREIGN MATTER EMBEDDED WITHIN THE PACKAGING. FOREIGN MATERIAL EMBEDDED IN THE PACKAGING MAY ORIGINATE DURING THE POCKET FORMING AND PACKAGE SEALING STEPS IN THE MANUFACTURING STEP. EIGHT UNITS WERE FOUND TO HAVE FOREIGN MATERIAL LOOSE WITHIN THE PACKAGING. ONE UNIT WAS FOUND TO HAVE FOREIGN MATERIAL EMBEDDED WITHIN THE ADHESIVE OF THE EXTENSION TUBING. THE FOREIGN MATERIAL WAS MOST LIKELY INTRODUCED DURING THE ASSEMBLY OR PACKAGING PROCESSES. AS THE DEVICES WERE SEALED, THE DEFECT OF FOREIGN MATTER CAN BE ATTRIBUTED TO THE MANUFACTURING OR PACKAGING PROCESS. ONE UNIT WAS FOUND TO HAVE BLACK MATERIAL EMBEDDED WITHIN THE WING. THE MATERIAL WAS DETERMINED TO BE A NON-FOREIGN, BURNT PARTICULATE RESIN. THESE SPECKS ARE A RESULT OF MATERIAL BUILD UP ON THE BARREL/SCREW BREAKING FREE DURING THE MOLDING PROCESS. MOLDS ARE PURGED BETWEEN LOTS TO REDUCE BUILDUP; HOWEVER, ONE LOT CAN SOMETIMES TAKE UP TO TEN DAYS TO PRODUCE. OPERATORS PERFORM GOOD MANUFACTURING PRACTICES AND GOWNING PER THE QUALITY PLAN. ENVIRONMENTAL CONTROLS AND INSPECTIONS FOR FOREIGN MATTER ARE PERFORMED TO MITIGATE THE OCCURRENCE OF THIS DEFECT. ADDITIONALLY, MANUFACTURING IS COVERED, WHERE POSSIBLE, TO REDUCE AND MITIGATE THE INTRODUCTION OF ENVIRONMENTAL FOREIGN MATERIAL. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. H3 OTHER TEXT : SEE H10.
IT WAS REPORTED THAT 17 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM - DUAL PORT 24 GA 0.75 IN CONTAINED FOREIGN MATTER ON THE DEVICE CANNULA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THIS IS A REPORT ABOUT FOREIGN MATTER (DIRT) ON NEXIVA."
IT WAS REPORTED THAT 17 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM - DUAL PORT 24 GA 0.75 IN CONTAINED FOREIGN MATTER ON THE DEVICE CANNULA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THIS IS A REPORT ABOUT FOREIGN MATTER (DIRT) ON NEXIVA."
IT WAS REPORTED THAT 17 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM - DUAL PORT 24 GA 0.75 IN CONTAINED FOREIGN MATTER ON THE DEVICE CANNULA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THIS IS A REPORT ABOUT FOREIGN MATTER (DIRT) ON NEXIVA."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 961439 | BD NEXIVA¿ CLOSED IV CATHETER SYSTEM - DUAL PORT 24 GA 0.75 IN | INTRAVASCULAR CATHETER | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. | 383531 | SEE H.10. | 30382903835318 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |