20 G X 1.16 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
Report
- Report Number
- 1710034-2016-00068
- Event Type
- Malfunction
- Date Received
- December 28, 2016
- Date of Event
- December 7, 2016
- Report Date
- January 23, 2017
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
- Product Code
- FOZ
- PMA / PMN Number
- K952861
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
ADDITIONAL INFORMATION: ON 1/9/2017, MEDWATCH (B)(6) WAS RECEIVED AND PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: "AN IV ATTEMPT WAS BEING MADE ON A PATIENT IN THE SURGICAL ICU. WHEN THE BUTTON ON THE SAFETY IV CATHETER WAS DEPRESSED, TO ENGAGE THE SAFETY DEVICE, THE BUTTON REMAINED DEPRESSED AND THE SAFETY DEVICE FAILED TO ENGAGE." THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION. DEVICE EVALUATION: ONE USED SAMPLE WAS RETURNED FOR EVALUATION. THE UNIT CONSISTED OF THE PROTECTION NEEDLE COVER IN PLACE OVER THE NEEDLE/HUB ASSEMBLY WITH BARREL. THE NEEDLE/HUB ASSEMBLY WAS PARTIALLY RETRACTED WITH THE BUTTON COMPLETELY DEPRESSED. A VISUAL/MICROSCOPIC INSPECTION OBSERVED: THE BARREL WAS SMASHED WITH STRESS MARKS. THERE WERE WHITE PATTERN MARKINGS ON THE BARREL AND THAT THE PATTERN MAKINGS COULD BE REMOVED. THE BARREL WAS NOT FULLY SEATED ON THE GRIP CAUSED BY THE SMASHING OF THE SIDES OF THE BARREL. THE NEEDLE WAS PUSHED TO THE OUT POSITION AND THE ACTIVATION BUTTON WAS RESET. A SECOND VISUAL/MICROSCOPIC INSPECTION REVEALED NO ANOMALIES OR MECHANICAL/PHYSICAL DAMAGE TO THE NEEDLE, SPRING, GRIP, NEEDLE/HUB OR EXCESSIVE GEL THAT WOULD CONTRIBUTE TO THE RETRACTION FAILURE. A FUNCTIONAL USE TEST WAS PERFORMED BY PRESSING THE SAFETY ACTIVATION BUTTON. THE NEEDLE WAS OBSERVED TO PARTIALLY RETRACT TO THE POINT WHERE THE BARREL WAS SMASHED CONFIRMING THAT THE DAMAGED/SMASHED BARREL HINDERED THE UNIT FROM FULLY RETRACTING. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6251800. MANUFACTURING ENGINEERS AND MOLDING ENGINEERS WERE CONSULTED AND COULD NOT DETERMINE IF THE REPORTED DAMAGE COULD HAVE BEEN CAUSED AT ANY OF THE MANUFACTURING STATIONS. CONCLUSION: AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. ALTHOUGH THE RETRACTION FAILURE REPORTED BY THE CUSTOMER WAS CONFIRMED WITH THE RETURNED UNIT AND NOTED TO BE DUE TO THE BARREL BEING DAMAGED AND SMASHED, IT COULD NOT BE DETERMINED IF THE DAMAGE RESULTED FROM MANUFACTURING OR FROM THE USER¿S ENVIRONMENT. THE SAMPLE RECEIVED HAD STRESS AND PATTERN MARKINGS ON THE SAFETY SHIELD (BARREL) AND WAS RECEIVED OUT OF THE PACKAGING.
A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).
ON 1/9/2017, MEDWATCH (B)(6) WAS RECEIVED AND PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: "AN IV ATTEMPT WAS BEING MADE ON A PATIENT IN THE SURGICAL ICU. WHEN THE BUTTON ON THE SAFETY IV CATHETER WAS DEPRESSED, TO ENGAGE THE SAFETY DEVICE, THE BUTTON REMAINED DEPRESSED AND THE SAFETY DEVICE FAILED TO ENGAGE." THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.
IT WAS REPORTED THAT AN IV INSERTION WAS ATTEMPTED WITH A 20 G X 1.16 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER BUT WHEN THE SAFETY ACTIVATION BUTTON WAS PRESSED, THE SAFETY FAILED TO ENGAGE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION. IT WAS ALSO REPORTED THAT A "MEDSUN REPORT" WAS FILED BUT THE REPORT NUMBER WAS NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 860831 | 20 G X 1.16 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER | INTRAVASCULAR CATHETER | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. | 6251800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |