BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
Report
- Report Number
- 1710034-2019-00425
- Event Type
- Malfunction
- Date Received
- April 16, 2019
- Date of Event
- March 28, 2019
- Report Date
- July 10, 2019
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
- Product Code
- FOZ
- UDI-DI
- 30382903825333
- PMA / PMN Number
- K110443
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE SAMPLES PROVIDED BY YOUR FACILITY. BD RECEIVED A TOTAL OF 41 INSYTE AUTOGUARD 20GA UNITS FROM THE FOLLOWING LOT NUMBERS: 8235933, 8304898, 8310640, 8197518, 8241920, 8037527 AND 8310635. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCE'S ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THESE BATCHES. THROUGH THE VISUAL/MICROSCOPIC EVALUATION OF THE UNITS, THERE WERE NO SIGNS OR EVIDENCE OF FOREIGN MATTER FOUND ON ANY OF THE COMPONENTS OF THE REPRESENTATIVE UNITS RECEIVED. THE CATHETER TIPS WERE FOUND ACCEPTABLE PER SPECIFICATION. THE RETURNED UNITS PROVIDED FOR EVALUATION MET AND PERFORMED PER THE REQUIRED MANUFACTURING SPECIFICATIONS. THERE WAS NO PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE FAILURES STATED IN YOUR REPORT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8235933. MEDICAL DEVICE EXPIRATION DATE: 2121-07-31. DEVICE MANUFACTURE DATE: 2018-08-01. MEDICAL DEVICE LOT #: 8304898. MEDICAL DEVICE EXPIRATION DATE: 2021-10-31. DEVICE MANUFACTURE DATE: 2018-11-01. MEDICAL DEVICE LOT #: 8310640. MEDICAL DEVICE EXPIRATION DATE: 2021-10-31. DEVICE MANUFACTURE DATE: 2018-11-01. MEDICAL DEVICE LOT #: 8197518. MEDICAL DEVICE EXPIRATION DATE: 2021-06-30. DEVICE MANUFACTURE DATE: 2018-07-01. MEDICAL DEVICE LOT #: 8241920. MEDICAL DEVICE EXPIRATION DATE: 2021-08-31. DEVICE MANUFACTURE DATE: 2018-09-01. MEDICAL DEVICE LOT #: 8037527. MEDICAL DEVICE EXPIRATION DATE: 2021-01-31. DEVICE MANUFACTURE DATE: 2018-02-01. MEDICAL DEVICE LOT #: 8310635. MEDICAL DEVICE EXPIRATION DATE: 2021-10-31. DEVICE MANUFACTURE DATE: 2018-11-01 . "
IT WAS REPORTED THAT THERE WERE 5 OCCURRENCES OF ADDITIONAL PLASTIC AROUND THE CATHETER WITH A BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE IS EXTRA PLASTIC AROUND THE CATHETER.
IT WAS REPORTED THAT THERE WERE 5 OCCURRENCES OF ADDITIONAL PLASTIC AROUND THE CATHETER WITH A BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE IS EXTRA PLASTIC AROUND THE CATHETER.
MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.
IT WAS REPORTED THAT THERE WERE 5 OCCURRENCES OF ADDITIONAL PLASTIC AROUND THE CATHETER WITH A BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE IS EXTRA PLASTIC AROUND THE CATHETER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 314355 | BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER | INTRAVASCULAR CATHETER | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. | SEE H.10 | 30382903825333 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |