BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BI-EXT SET 15CM MACRO BORE SPIN NUT

    MDR report key: 21827830 · Received April 11, 2025

    Report

    Report Number
    9610847-2025-00101
    Event Type
    Malfunction
    Date Received
    April 11, 2025
    Date of Event
    March 24, 2025
    Report Date
    April 22, 2025
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K142527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 385161 AND LOT NUMBER 2111731. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. THERE ARE QUALITY CONTROLS CURRENTLY IN PLACE TO DETECT THIS TYPE OF DEFECT DURING THE PRODUCTION PROCESS. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BI-EXT SET 15CM MACRO BORE SPIN NUT CRACKED AND LEAKED CRACKING HUBS CAUSING LEAKS AND LEAKAGE OF CONNECTED DRIP INFUSIONS. CRACKED HUBS CAUSING LEAKAGE AND LEAKAGE OF CONNECTED DRIP INFUSIONS. THE HEAVY PLASTIC OF WHICH THEY ARE MADE PUTS A STRAIN ON THE PERIPHERAL INSERTION DEVICE IN SMALL PATIENTS, CAUSING IT TO DISLODGE FREQUENTLY. IN ADDITION, THE SEALING ON THE THREAD IS PROBLEMATIC, OFTEN MAKING IT IMPOSSIBLE TO UNSCREW THE EXTENSION TUBE AGAIN. WHEN DID THE INCIDENT OCCUR? DURING USE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1006698 BD BI-EXT SET 15CM MACRO BORE SPIN NUT INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 2111731

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown