BD INSYTE¿ AUTOGUARD¿ WINGED SHIELDED IV CATHETER 18GA 1.16IN (1.3 X 30 MM)
Report
- Report Number
- 1710034-2020-00168
- Event Type
- Malfunction
- Date Received
- March 13, 2020
- Date of Event
- February 19, 2020
- Report Date
- April 23, 2020
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
- Product Code
- FOZ
- UDI-DI
- 30382903815440
- PMA / PMN Number
- K952861
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
H.6. INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE SAMPLES SUBMITTED FOR EVALUATION. BD RECEIVED ONE USED, INSYTE AUTOGUARD 18GA UNIT IN AN OPENED PACKAGE AND 18 UNUSED UNITS IN SEALED PACKAGES FROM MATERIAL. NUMBER 381544, LOT NUMBER 9113561. A VISUAL/MICROSCOPIC EVALUATION AND TESTING WAS PERFORMED ON THE RETURNED UNITS. FIRST ON THE USED UNIT, THE NEEDLE COVER WAS REMOVED IN A STRAIGHT OUTWARD MOTION AND THE CATHETER WAS INSPECTED. THERE WERE NO BENDS, CRIMPS, HOLES, KINKS, SPLITS, OR WRINKLES NOR A NEEDLE SPEARING THROUGH THE CATHETER TUBING. THERE WAS NO MECHANICAL/PHYSICAL DAMAGE TO ANY OF THE COMPONENTS (SPRING, HUB, GRIP, BUTTON) OR EVIDENCE OF ADHESIVE ON THE BUTTON OR HUB. THE LIE DISTANCE WAS WITHIN THE SPECIFICATIONS. THE HUB WAS MANUALLY TWISTED TO ENSURE IT ROTATED AS INTENDED. THE HUB ROTATED WITH NO ISSUES. NEXT NEEDLE RETRACTION TESTING WAS PERFORMED. THE CATHETER/ADAPTER EASILY SLID OFF THE NEEDLE INTO THE ARTIFICIAL VEIN AND THE NEEDLE RETRACTED INTO THE SAFETY BARREL. THE USED UNIT PASSED THE NEEDLE RETRACTIONS WITH NO ISSUES. THE SAME TESTING WAS THEN PERFORMED ON THE REMAINING 18 UNITS. ALL UNITS PASSED TESTING WITH NO DEFECTS OBSERVED. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. 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.
IT WAS REPORTED THAT 2 BD INSYTE¿ AUTOGUARD¿ WINGED SHIELDED IV CATHETERS 18GA 1.16IN (1.3 X 30 MM) EXPERIENCED A NEEDLE THAT WOULD NOT RETRACT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 381544, BATCH NO.: 9113561. PER COMPLAINT FORM: NURSE REPORTED THAT THE NEEDLE WOULD NOT RETRACT WHEN BUTTON TO RETRACT WAS PUSHED. EVEN WHEN SHE BROUGHT IT OUT, IT STILL WOULD NOT RETRACT. SECOND NURSE REPORTED THIS HAS ALSO HAPPENED TO HER RECENTLY. BOTH NURSES WERE USING A 18 GUAGE (REF 381544) INSYTE AUTOGUARD IV CATHETER. THE LOT NUMBER FOR THE ONE THAT MALFUNCTIONED TONIGHT IS 9113561.
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 2 BD INSYTE¿ AUTOGUARD¿ WINGED SHIELDED IV CATHETERS 18GA 1.16IN (1.3 X 30 MM) EXPERIENCED A NEEDLE THAT WOULD NOT RETRACT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 381544, BATCH NO.: 9113561. PER COMPLAINT FORM: NURSE REPORTED THAT THE NEEDLE WOULD NOT RETRACT WHEN BUTTON TO RETRACT WAS PUSHED. EVEN WHEN SHE BROUGHT IT OUT, IT STILL WOULD NOT RETRACT. SECOND NURSE REPORTED THIS HAS ALSO HAPPENED TO HER RECENTLY. BOTH NURSES WERE USING A 18 GUAGE (REF 381544) INSYTE AUTOGUARD IV CATHETER. THE LOT NUMBER FOR THE ONE THAT MALFUNCTIONED TONIGHT IS 9113561.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 295975 | BD INSYTE¿ AUTOGUARD¿ WINGED SHIELDED IV CATHETER 18GA 1.16IN (1.3 X 30 MM) | INTRAVASCULAR CATHETER | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. | 381544 | 9113561 | 30382903815440 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |