BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ WINGED SHIELDED IV CATHETER 18GA 1.16IN (1.3 X 30 MM)

    MDR report key: 9990341 · Received April 23, 2020

    Report

    Report Number
    1710034-2020-00271
    Event Type
    Malfunction
    Date Received
    April 23, 2020
    Date of Event
    April 2, 2020
    Report Date
    June 4, 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
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10 DEVICE AVAILABLE FOR EVAL YES, RETURNED TO MANUFACTURER ON: 2020-05-01. H.6. INVESTIGATION SUMMARY OUR QUALITY ENGINEER INSPECTED THE SAMPLE AND PHOTOGRAPHS SUBMITTED FOR EVALUATION. BD RECEIVED ONE USED UNIT. THE UNIT IS PARTIALLY RETRACTED WITH THE BUTTON COMPLETELY DEPRESSED AND THERE ARE TRACES OF DRY MEDIA. THERE IS NO DAMAGE TO THE OPENED PACKAGE FROM LOT NUMBER 9241791 WHICH HAS A VERY SMALL PIECE OF SURGICAL TAPE ADHERED AT THE TOP WEB (LABEL). IN ADDITION, TWO PHOTOGRAPHS WERE ALSO PROVIDED WHICH DISPLAYED SIMILARITIES TO THAT OF THE RETURNED UNIT, BUT NOT SUFFICIENT EVIDENCE TO IDENTIFY THE ROOT CAUSE. THROUGH THE VISUAL-MICROSCOPIC EVALUATION, THE BARREL ON THE RETURNED UNIT HAS STRESS MARKS AND IS CRACKED OPEN. THERE WERE NO OTHER ANOMALIES OR DAMAGE OBSERVED. A FUNCTIONAL TEST WAS PERFORMED WHERE THE NEEDLE WAS RESET TO THE OUT POSITION AND THE ACTIVATION BUTTON WAS SECURED. THE ACTIVATION BUTTON WAS DEPRESSED AT WHICH TIME THE NEEDLE RETRACTED AND STOPPED WHERE THE BARREL IS DAMAGED AND SMASHED, THEREFORE CONFIRMING THE DAMAGE TO THE BARREL HINDERED THE NEEDLE RETRACTION. THIS WAS PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE REPORTED DEFECT. 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ WINGED SHIELDED IV CATHETER 18GA 1.16IN (1.3 X 30 MM) EXPERIENCED A NEEDLE THAT WAS PARTIALLY RETRACTED AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 381544 BATCH NO: 9241791 EVENT DESCRIPTION: WE HAD AN ISSUE WITH ONE OF THE BD #18G IV INSYTE AUTOGUARD WINGED CATH NDL ¿ REF #381544. ACCORDING TO THE STAFF MEMBER USING THE #18G IV CATH NEEDLE, AFTER THE STICK THE SAFETY RETRACTION DID NOT FULLY RETRACT LEAVING A PORTION OF THE NEEDLE EXPOSED AND PLACING THE STAFF AT RISK FOR EXPOSURE.

    Additional Manufacturer Narrative · 1

    DATE OF BIRTH: NO BIRTH DATE WAS PROVIDED WITH THE PATIENT'S AGE, THEREFORE A DEFAULT DATE OF BIRTH WAS LISTED. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ WINGED SHIELDED IV CATHETER 18GA 1.16IN (1.3 X 30 MM) EXPERIENCED A NEEDLE THAT WAS PARTIALLY RETRACTED AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 381544, BATCH NO: 9241791. EVENT DESCRIPTION: WE HAD AN ISSUE WITH ONE OF THE BD #18G IV INSYTE AUTOGUARD WINGED CATH NDL ¿ REF #381544. ACCORDING TO THE STAFF MEMBER USING THE #18G IV CATH NEEDLE, AFTER THE STICK THE SAFETY RETRACTION DID NOT FULLY RETRACT LEAVING A PORTION OF THE NEEDLE EXPOSED AND PLACING THE STAFF AT RISK FOR EXPOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456733 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 9241791 30382903815440

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other