BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD BC WINGED SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY

    MDR report key: 11490422 · Received March 15, 2021

    Report

    Report Number
    1710034-2021-00187
    Event Type
    Malfunction
    Date Received
    March 15, 2021
    Date of Event
    February 9, 2021
    Report Date
    June 15, 2021
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K110443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL?: YES. D10: RETURNED TO MANUFACTURER ON: 3/22/2021. H6: INVESTIGATION: BD RECEIVED AN 18 GAUGE INSYTE AUTOGUARD BLOOD CONTROL UNIT FROM LOT 0230749 FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER VISUALLY INSPECTED THE RETURNED UNIT AND OBSERVED BLOOD ON THE OUTSIDE OF THE HUB, ON THE SPRING AND ON THE BACKSIDE OF THE VENT PLUG. THIS WAS INDICATIVE OF A VENT PLUG FAILURE. NEXT, THE CATHETER HUB WAS REMOVED FROM THE PLASTIC BARREL AND CLEANED USING A BLEACH SOLUTION SO THAT THE VENT PLUG COULD BE INSPECTED FURTHER. VISUAL INSPECTION OF THE VENT PLUG REVEALED THAT IT WAS DAMAGED CREATING AN UNEVEN SURFACE. BASED OFF THE VISUAL INSPECTION AND TESTING THE ENGINEER WAS UNABLE TO VERIFY THE REPORTED DEFECT BUT COULD IDENTIFY THAT THERE WAS LEAKAGE BEYOND THE VENT PLUG AND DAMAGE TO THE VENT PLUG. IT WAS DETERMINED THAT THIS WAS A MANUFACTURING RELATED DEFECT THAT OCCURRED DURING ASSEMBLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BLOOD "SPLASHED" ONTO THE CAREGIVERS BLOUSE DURING USE WHEN THE BD INSYTE¿ AUTOGUARD¿ BC WINGED SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY WAS INSERTED INTO THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "DESCRIPTION OF THE FACTS: WHEN THE CATHETER WAS INSERTED, WHEN THE TROCAR WAS SECURED IN THE SECURED CHAMBER, THE PATIENT'S BLOOD FILLED THE CHAMBER AND SPLASHED ON THE CAREGIVER. CONSEQUENCES OBSERVED: CHANGE OF BLOUSE: NO SERIOUS CONSEQUENCES FOR THE PATIENT AND THE BLOOD WAS SPLASHED ON THE CAREGIVER."

    Additional Manufacturer Narrative · 1

    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 BLOOD "SPLASHED" ONTO THE CAREGIVERS BLOUSE DURING USE WHEN THE BD INSYTE¿ AUTOGUARD¿ BC WINGED SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY WAS INSERTED INTO THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "DESCRIPTION OF THE FACTS: WHEN THE CATHETER WAS INSERTED, WHEN THE TROCAR WAS SECURED IN THE SECURED CHAMBER, THE PATIENT'S BLOOD FILLED THE CHAMBER AND SPLASHED ON THE CAREGIVER. CONSEQUENCES OBSERVED: CHANGE OF BLOUSE NO SERIOUS CONSEQUENCES FOR THE PATIENT AND THE BLOOD WAS SPLASHED ON THE CAREGIVER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384797 BD INSYTE AUTOGUARD BC WINGED SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 0230749

    Patients

    Seq Age Sex Outcome Treatment
    1