BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
Report
- Report Number
- 1710034-2023-00326
- Event Type
- Malfunction
- Date Received
- March 28, 2023
- Date of Event
- March 10, 2023
- Report Date
- April 7, 2023
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
- Product Code
- FOZ
- UDI-DI
- 00382903814343
- PMA / PMN Number
- K201075
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
OUR QUALITY ENGINEER INSPECTED THE SAMPLE SUBMITTED FOR EVALUATION. BD RECEIVED ONE UNSEALED 20GA X 1.16IN. INSYTE AUTOGUARD FROM LOT NUMBER 2118372. THE DEVICE WAS RECEIVED RETRACTED. THE SAFETY MECHANISM WAS DISENGAGED, AND A FUNCTIONAL TEST REVEALED THAT THE NEEDLE RETRACTION WAS DELAYED AND THE TIME TO RETRACT EXCEEDED THE SPECIFICATION. MICROSCOPIC ANALYSIS WAS PERFORMED TO INVESTIGATE FOR ANY DRY ADHESIVE THAT MAY HAVE POURED BEHIND THE BUTTON OR BETWEEN THE NEEDLE HUB AND THE NEEDLE GRIP. ALTHOUGH NO ADHESIVE WAS OBSERVED, IT IS LIKELY DUE TO EXCESS GEL IN THE SAFETY MECHANISM. INCORRECT EQUIPMENT SETTINGS DURING MANUFACTURING MAY CAUSE EXCESSIVE GEL WHICH WOULD CAUSE SLOW RETRACTION. A QUALITY CONTROL PLAN TO CHECK THE WEIGHT AT SET-UP IS IN PLACE TO MITIGATE THE OCCURRENCE OF THIS DEFECT. AS THE DEVICE RETRACTED, THE REPORT OF RETRACTION FAILURE COULD NOT BE CONFIRMED, HOWEVER DELAYED RETRACTION WAS CONFIRMED. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. HOWEVER, A TREND HAS BEEN IDENTIFIED FOR THE REPORTED FAILURE AND CORRECTIVE ACTIONS HAVE BEEN INITIATED TO INVESTIGATE THIS TYPE OF INCIDENT AND IDENTITY THE ROOT CAUSE. H3 OTHER TEXT : SEE H10.
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER NEEDLE WOULD NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PRODUCT BELOW HAS A SERIOUS SAFETY ISSUE. THE ANGIOCATH NEEDLE DOES NOT RETRACT AS IT WAS DESIGNED TO DO. THIS PUTS CAREGIVERS AND PATIENTS AT RISK FOR NEEDLE STICK. INSYTE AUTOGUARD NEEDLE WOULD NOT SAFETY. IT IS TO MY UNDERSTANDING THAT THE NEEDLE SAFETY CONCERN HAS IMPACTED MULTIPLE LOTS. LOT 211832 BEING ONE OF THEM. 13MAR2023: ALL OF THE LOT NUMBERS THAT I GAVE TO OUR CENTRAL SUPPLY XXXX, WERE PROVIDED PRODUCTS WITH SLOW RETRACTION. THE ISSUE IS CONSTANT AND I AM NOT SURE IF ANY OTHER LOT NUMBERS ARE AFFECTED. IT IS BOTH SLOW RETRACTION AND NO RETRACTION AT ALL.
IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER NEEDLE WOULD NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PRODUCT BELOW HAS A SERIOUS SAFETY ISSUE. THE ANGIOCATH NEEDLE DOES NOT RETRACT AS IT WAS DESIGNED TO DO. THIS PUTS CAREGIVERS AND PATIENTS AT RISK FOR NEEDLE STICK. INSYTE AUTOGUARD NEEDLE WOULD NOT SAFETY. IT IS TO MY UNDERSTANDING THAT THE NEEDLE SAFETY CONCERN HAS IMPACTED MULTIPLE LOTS. LOT 211832 BEING ONE OF THEM. 13MAR2023: ALL OF THE LOT NUMBERS THAT I GAVE TO OUR CENTRAL SUPPLY XXXX, WERE PROVIDED PRODUCTS WITH SLOW RETRACTION. THE ISSUE IS CONSTANT AND I AM NOT SURE IF ANY OTHER LOT NUMBERS ARE AFFECTED. IT IS BOTH SLOW RETRACTION AND NO RETRACTION AT ALL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1767236 | BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER | INTRAVASCULAR CATHETER | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. | 381434 | 2118372 | 00382903814343 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |