BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
Report
- Report Number
- 1710034-2021-01116
- Event Type
- Malfunction
- Date Received
- January 12, 2022
- Date of Event
- December 16, 2021
- Report Date
- January 31, 2022
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
- Product Code
- FOZ
- PMA / PMN Number
- K201075
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHARMACIST
- Health Professional
- Yes
Narratives
A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 1/4/2022. H.6. INVESTIGATION: OUR QUALITY ENGINEER INSPECTED THE SAMPLE AND PHOTOGRAPHS SUBMITTED FOR EVALUATION. BD RECEIVED ONE USED 20GA X 1.16IN. INSYTE AUTOGUARD BC PRO UNIT FROM LOT NUMBER 1130375. ADDITIONALLY, FOUR PHOTOS WERE PROVIDED FOR INVESTIGATION. A GROSS VISUAL INSPECTION OF THE RETURNED UNIT FOUND THAT THE CATHETER TUBING WAS TORN AT THE WEDGE. THE WEDGE APPEARED TO PROTRUDE THROUGH THE TUBING. THIS TYPE OF DAMAGE IS INDICATIVE OF LEAKAGE. THE REPORTED ISSUE WAS CONFIRMED. THIS WAS PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE REPORTED DEFECT. THIS TYPE OF DEFECT MAY OCCUR DURING MANUFACTURING IF THE TUBING IS DAMAGED DUE TO A FEEDER JAM. THERE IS A 100% VISION INSPECTION SYSTEM IN PLACE TO MEASURE THE FLARE LENGTH AND REJECT ANY PARTS THAT ARE OUT OF SPECIFICATION. A DAMAGED TUBING WOULD LIKELY BE FLARED INCORRECTLY AND BE REJECTED BY THE VISION SYSTEM. HOWEVER, IF THE HEIGHT OF THE FLARE VARIES AROUND THE WHOLE DIAMETER, AS SEEN IN THE RETURNED UNIT, IT MAY PASS THROUGH VISION SYSTEM. ADDITIONALLY, LEAK TESTS ARE PERFORMED PER THE QUALITY PLAN TO MITIGATE THE RISK FROM THIS TYPE OF DEFECT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.
IT WAS REPORTED THAT 1 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CUSTOMER REPORTED THE CONTRAST AGENT LEAKED FROM THE CONNECTION BETWEEN THE CATHETER AND THE CATHETER HUB.
IT WAS REPORTED THAT 1 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CUSTOMER REPORTED THE CONTRAST AGENT LEAKED FROM THE CONNECTION BETWEEN THE CATHETER AND THE CATHETER HUB.
IT WAS REPORTED THAT 1 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CUSTOMER REPORTED THE CONTRAST AGENT LEAKED FROM THE CONNECTION BETWEEN THE CATHETER AND THE CATHETER HUB.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 784584 | BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER | INTRAVASCULAR CATHETER | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. | 1130375 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |