BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONNECTA STOPCOCK

    MDR report key: 9695989 · Received February 11, 2020

    Report

    Report Number
    9610847-2020-00045
    Event Type
    Malfunction
    Date Received
    February 11, 2020
    Date of Event
    January 17, 2020
    Report Date
    March 24, 2020
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMG
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBERS 9165983 AND 9032897. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT AND ALL QUALITY INSPECTIONS WERE FOUND TO BE WITHIN SPECIFICATION. TO FURTHER INVESTIGATE THIS ISSUE, TWO UNUSED SAMPLES AND ONE USED SAMPLE WERE PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE USED SAMPLE, THE PRODUCT WAS OBSERVED SEPARATED, CONFIRMING THE REPORTED INCIDENT. THE TWO UNUSED SAMPLES WERE EXAMINED AND FUNCTIONALLY TESTED; NO SIGNS OF DAMAGE WERE OBSERVED IN THE UNUSED SAMPLES. IT IS POSSIBLE THAT THIS INCIDENT RESULTED DUE TO A LACK OF SOLVENT-BASED ADHESIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD CONNECTA¿ STOPCOCK LEAKED BLOOD DURING USE THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH. VERBATIM: ¿BD CONNECTA WITH EXTENSION WAS CONNECTED TO A BLOOD BAG ON THE SIDE OF THE THREE-WAY VALVE. WHEN THE USER WANTED TO CONNECT THE CONNECTOR TO THE PERIPHERAL VENOUS CATHETER, THIS CONNECTOR DETACHED FROM THE EXTENSION TUBE OF THE BD CONNECTA. THE PRODUCT, WHICH WAS FILLED WITH THE BLOOD FROM THE PRESERVED BLOOD, WAS CLEANED WITH NACL, BUT IS STILL CONTAMINATED.¿

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD CONNECTA¿ STOPCOCK LEAKED BLOOD DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH. VERBATIM: ¿BD CONNECTA WITH EXTENSION WAS CONNECTED TO A BLOOD BAG ON THE SIDE OF THE THREE-WAY VALVE. WHEN THE USER WANTED TO CONNECT THE CONNECTOR TO THE PERIPHERAL VENOUS CATHETER, THIS CONNECTOR DETACHED FROM THE EXTENSION TUBE OF THE BD CONNECTA. THE PRODUCT, WHICH WAS FILLED WITH THE BLOOD FROM THE PRESERVED BLOOD, WAS CLEANED WITH NACL, BUT IS STILL CONTAMINATED.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160247 BD CONNECTA STOPCOCK STOPCOCK FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 9165983

    Patients

    Seq Age Sex Outcome Treatment
    1 Other