BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD Q-SYTE¿ EXTENSION SET MICRO BORE

    MDR report key: 12750680 · Received November 4, 2021

    Report

    Report Number
    9610847-2021-00531
    Event Type
    Malfunction
    Date Received
    November 4, 2021
    Date of Event
    October 6, 2021
    Report Date
    December 6, 2021
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    30382903851028
    PMA / PMN Number
    K013621
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2021-11-03. H6: INVESTIGATION SUMMARY : OUR QUALITY ENGINEER INSPECTED THE 10 SAMPLES SUBMITTED FOR EVALUATION. THE SAMPLES WERE ALL MIXED IN THE SHIPMENT PACKAGING, SO IT WAS NOT POSSIBLE TO DETERMINE WHICH SAMPLE BELONGED TO WHICH LOT DURING THE INVESTIGATION. THE REPORTED ISSUE WAS NOT CONFIRMED UPON TESTING OF THE SAMPLES. ALL THE SAMPLES UNDERWENT OUR INTERNAL LEAKAGE TESTING AND NONE OF THEM EXPERIENCED ANY LEAKAGE. SINCE THE FAILURE WAS NOT CONFIRMED A MANUFACTURING ROOT CAUSE COULD NOT BE IDENTIFIED. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD Q-SYTE¿ EXTENSION SET MICRO BORE, THE DEVICE EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE LOCK WAS LEAKING ALONG THE EDGE. THE LOCKS HAD NOT YET BEEN USED FOR ADMINISTERING MEDICINES. THE EMERGENCY NURSES PUNCTURE THEIR IV WITHOUT GLOVES, BUT I HAVE NOT RECEIVED ANY REPORT OF EXPOSURE TO MUCOUS MEMBRANES.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1082697, MEDICAL DEVICE EXPIRATION DATE: 2026-03-31, DEVICE MANUFACTURE DATE: 2021-04-28. MEDICAL DEVICE LOT #: 1021726, MEDICAL DEVICE EXPIRATION DATE: 2026-01-31, DEVICE MANUFACTURE DATE: 2021-03-01. MEDICAL DEVICE LOT #: 1140030, MEDICAL DEVICE EXPIRATION DATE: 2026-03-31, DEVICE MANUFACTURE DATE: 2021-06-15. 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 WHEN USING THE BD Q-SYTE¿ EXTENSION SET MICRO BORE, THE DEVICE EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE LOCK WAS LEAKING ALONG THE EDGE. THE LOCKS HAD NOT YET BEEN USED FOR ADMINISTERING MEDICINES. THE EMERGENCY NURSES PUNCTURE THEIR IV WITHOUT GLOVES, BUT I HAVE NOT RECEIVED ANY REPORT OF EXPOSURE TO MUCOUS MEMBRANES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1653231 BD Q-SYTE¿ EXTENSION SET MICRO BORE INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 385102 SEE H.10. 30382903851028

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown