BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
Report
- Report Number
- 1710034-2021-01102
- Event Type
- Malfunction
- Date Received
- January 7, 2022
- Date of Event
- December 11, 2021
- Report Date
- January 20, 2022
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
- Product Code
- FOZ
- UDI-DI
- 00382903818235
- PMA / PMN Number
- K952861
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- 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.
INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE SAMPLE AND PHOTOGRAPHS SUBMITTED FOR EVALUATION. BD RECEIVED ONE USED 22GA X 1.00IN. INSYTE AUTOGUARD UNIT FROM LOT NUMBER 1111837. IN ADDITION, FIVE PHOTOGRAPHS WERE RECEIVED WHICH DISPLAYED SIMILARITIES TO THAT OF THE RETURNED UNIT. A GROSS VISUAL INSPECTION OF THE RETURNED UNIT FOUND THAT THE LUER THREADS WERE DEFORMED. FURTHER INSPECTION UNDER A MICROSCOPE FOUND THAT THE LUER THREADS WHERE THE DEFORMATIONS WERE PRESENT APPEARED TO BE FLATTENED CAUSING MATERIAL TO PROTRUDE OUT. DUE TO THE SIZE OF THESE DEFORMITIES, A PROPER LUER CONNECTION COULD NOT BE ACHIEVED. THE DEFECT OF ¿ADAPTER/CONNECTER DEFECTIVE/DAMAGED¿ WAS CONFIRMED. THIS WAS THE PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE. DAMAGE OR DEFORMATION TO THE LUER THREADS MAY OCCUR ANYWHERE WHERE THE ADAPTER LUER ENCOUNTERS EQUIPMENT DUE TO A MISALIGNMENT. PREVENTATIVE MAINTENANCE (PM) IS PERFORMED TO ENSURE THE EQUIPMENT IS RUNNING PROPERLY. PM RECORDS WERE VERIFIED TO BE UP TO DATE DURING THE PRODUCTION OF THIS LOT. IN ADDITION, 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 THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER WOULD NOT CONNECT TO THE EXTENSION TUBING. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER CATHETER PLACEMENT, THE HCP ATTEMPTED TO CONNECT IAG TO AN EXTENSION TUBING BUT COULDN'T CONNECT IT. EVEN WHEN THE EXTENSION TUBING WAS REPLACED, THE CONNECTION COULD NOT BE PERFORMED. THE HCP THEN REMOVED THE CATHETER AND USED ANOTHER NEW IAG, WHICH RESULTED IN SUCCESSFUL CONNECTION WITH NO PROBLEM.
IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER WOULD NOT CONNECT TO THE EXTENSION TUBING. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER CATHETER PLACEMENT, THE HCP ATTEMPTED TO CONNECT IAG TO AN EXTENSION TUBING BUT COULDN'T CONNECT IT. EVEN WHEN THE EXTENSION TUBING WAS REPLACED, THE CONNECTION COULD NOT BE PERFORMED. THE HCP THEN REMOVED THE CATHETER AND USED ANOTHER NEW IAG, WHICH RESULTED IN SUCCESSFUL CONNECTION WITH NO PROBLEM.
IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER WOULD NOT CONNECT TO THE EXTENSION TUBING. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER CATHETER PLACEMENT, THE HCP ATTEMPTED TO CONNECT IAG TO AN EXTENSION TUBING BUT COULDN'T CONNECT IT. EVEN WHEN THE EXTENSION TUBING WAS REPLACED, THE CONNECTION COULD NOT BE PERFORMED. THE HCP THEN REMOVED THE CATHETER AND USED ANOTHER NEW IAG, WHICH RESULTED IN SUCCESSFUL CONNECTION WITH NO PROBLEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 993250 | BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER | INTRAVASCULAR CATHETER | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. | 381823 | 1111837 | 00382903818235 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |