BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOCK¿ MALE ADAPTER

    MDR report key: 16080784 · Received December 30, 2022

    Report

    Report Number
    2243072-2022-02258
    Event Type
    Malfunction
    Date Received
    December 30, 2022
    Date of Event
    December 14, 2022
    Report Date
    March 2, 2023
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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: 03-MAR-2023. H6:INVESTIGATION SUMMARY A COMPLAINT OF BROKEN MALE LUER WAS RECEIVED FROM THE CUSTOMER. SAMPLES WERE SENT BACK TO NAMC FOR REVIEW. THE SAMPLES WERE INVESTIGATED, ALONG WITH THE MOLDING AND PROCESS GROUP, AND THERE IS NO CONDITION PRESENT DURING NAMC'S MOLDING PROCESS THAT WOULD BE RELATED TO THIS TYPE OF DEFECT. LOT 1074981 HAD A SATORIUS MOISTURE ANALYZER CHECK EACH SHIFT TO ENSURE THE RESIN USED TO CREATE THE MALE LL ADAPTOR PARTS WERE ACCEPTABLE. ALL ANALYZER CHECKS PASSED FOR THIS LOT. ALONG THE PART THERE IS A WHITE, STRESS FRACTURE IN COLD STATE AFTER IT WAS FULLY ASSEMBLED. IF THE PART DAMAGE CAME FROM THE MOLDING PROCESS, THE PART WOULD DISPLAY DAMAGE ON THE TOP OF THE LUER. THE MALE LL ADAPTOR WAS NOTED TO BE THREADED ONTO THE COMPONENT EXTREMELY TIGHT. NAMC DOES NOT ASSEMBLE THE COMPONENT AND THERE IS NO INDICATION THAT THIS DEFECT IS A MOLDING DEFECT, THEREFORE THIS DEFECT CANNOT BE CONFIRMED. THERE HAVE BEEN NO QUALITY NOTIFICATIONS FOR THIS BATCH THAT WAS RELATED TO THIS CONDITION OF "DAMAGED/ BROKEN" FOR MATERIAL 1001-143-022 AND LOT 1074981. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS.

    Additional Manufacturer Narrative · 0

    OEM MANUFACTURER: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS MOLDING COE. THIS SITE IS AN OEM MANUFACTURING SITE. (B)(4). MEDICAL DEVICE EXPIRATION DATE: NA. 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 · 0

    IT WAS REPORTED THAT THE BD LUER-LOCK¿ MALE ADAPTER BROKE DURING THE REMOVAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AFTER ADMINISTRATION OF AN ANTICANCER DRUG(DOCETAXEL), 1001-143-022 WAS BROKE DURING REMOVAL...THERE WERE NO EXTERNAL FACTORS SUCH AS ADHESIVE EFFECTS OR IMPACT... WHEN BREAK OCCURRED WAS THERE ANY LEAKAGE OF THE ANTI-CANCER DRUG? ¿ NO IF SO, WAS ANYONE EXPOSED ADVERSELY TO THE LEAK? ¿ NO WAS ANY MEDICAL INTERVENTION REQUIRED? ¿ NO".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOCK¿ MALE ADAPTER BROKE DURING THE REMOVAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AFTER ADMINISTRATION OF AN ANTICANCER DRUG(DOCETAXEL), 1001-143-022 WAS BROKE DURING REMOVAL. THERE WERE NO EXTERNAL FACTORS SUCH AS ADHESIVE EFFECTS OR IMPACT. WHEN BREAK OCCURRED WAS THERE ANY LEAKAGE OF THE ANTI-CANCER DRUG? NO. IF SO, WAS ANYONE EXPOSED ADVERSELY TO THE LEAK? NO. WAS ANY MEDICAL INTERVENTION REQUIRED? NO".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2424479 BD LUER-LOCK¿ MALE ADAPTER INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 1074981

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown