BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FEMALE LL ADAPTOR

    MDR report key: 19937705 · Received August 8, 2024

    Report

    Report Number
    9616066-2024-01107
    Event Type
    Malfunction
    Date Received
    August 8, 2024
    Date of Event
    July 10, 2024
    Report Date
    August 15, 2024
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    70885403484300
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED BLACK SPECS IN FEMALE LUER LOK, AND RETURNED PICTURES OF 85 SAMPLES OF MATERIAL 1023-187-071, LOT 3331478. THE PRODUCT IS MANUFACTURED AT NORTH AMERICA MOLDING CENTER (NAMC), WHO CONDUCTED THE INVESTIGATION. NAMC FOUND THE ISSUE TO BE RELATED TO THE MANUFACTURING PROCESS. THE ROOT CAUSE FOR THIS DEFECT IS ATTRIBUTED TO MATERIAL DEGRADATION DUE TO OVERHEATING OF THE RESIN IN THE BARREL. THIS CREATES EMBEDDED FOREIGN MATTER ON THE PARTS DURING THE MOLD CYCLING AS THE OVERHEATED MATERIAL FLOWS THROUGH THE SYSTEM. NAMC RECOMMENDS SCRAPPING THE REMAINDER OF THE BATCH ALONG WITH DISCARDING BAG 198. A PCC IS OPEN TO ADD THE AUTOPURGING CYCLING PROGRAM TO THE MOLD TO AVOID THE DEGRADED MATERIAL FROM FLOWING THOUGH THE MOLD WITHOUT PURGING IT COMPLETELY. ADDITIONALLY, A QUALITY ALERT IS IN PLACE TO NOTIFY AND IMPLEMENT AWARENESS IN THE PRODUCTION RELATED TO THIS DEFECT DURING THE IN PROCESS INSPECTIONS. THE DHR REVIEW WAS PERFORMED ON THE BATCH #3331478 AT NAMC. THERE WERE NO QN¿S RELATED TO THIS CONDITION. A TOTAL OF 85 FUNCTIONAL GAGING AND VISUAL INSPECTIONS WERE PERFORMED DURING PRODUCTION OF THIS BATCH WITH ACCEPTABLE RESULTS. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. YOUR ASSISTANCE IN THIS MATTER HAS BEEN HELPFUL IN TREND IDENTIFICATION AND SUPPORTING OUR COMMITMENT TO CONTINUOUS QUALITY IMPROVEMENT. SHOULD THERE BE ANY ADDITIONAL QUESTIONS AS IT RELATES TO THIS (B)(4), PLEASE CONTACT YOUR SALES SUPPORT REPRESENTATIVE, (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD FEMALE LL ADAPTOR HAD FOREIGN MATTER THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM: IT WAS REPORTED BY CUSTOMER THAT CONTAMINANTS - BLACK SPECS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1530797 BD FEMALE LL ADAPTOR INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A. DE C.V. 3331478 70885403484300

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown