BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MALE LL ADAPTOR

    MDR report key: 15262818 · Received August 19, 2022

    Report

    Report Number
    9616066-2022-01182
    Event Type
    Malfunction
    Date Received
    August 19, 2022
    Date of Event
    July 19, 2022
    Report Date
    September 26, 2022
    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
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER NAME AND ADDRESS: FIRST NAME: (B)(6). A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A COMPLAINT OF THE CUSTOMER FINDING PACKAGES DAMAGED AND TORN WAS RECEIVED. SAMPLES OF THE BAGS WERE NOT AVAILABLE FOR REVIEW AT NAMC, HOWEVER PICTURES WERE PROVIDED OF THE PUNCTURED BAGS. IN THE PHOTO, THE PACKAGING IS SEEN TO BE DAMAGED. A HISTORICAL PART CODE WAS PERFORMED WITH NO INSTANCES OF PUNCTURED BAGS FOR THE MALE LL ADAPTOR BEING RECORDED. ADDITIONALLY, REVIEWAL OF THE PUNCTURED BAG PICTURES WAS CONDUCTED WITH THE PRODUCTION SUPERVISORS, AND THE PROCESS FOR COLLECTING AND SEALING THE PACKAGING OF THESE PARTS IS MANUAL WITH NO CURRENT PROCESS INVOLVING A WAY FOR PUNCTURING OF THE PACKAGED PRODUCT OCCURRING. IF A BAG WERE SOMEHOW PUNCTURED DURING PRODUCT, THIS DEFECT WOULD BE NOTED IN THE LOT RECORDED. THERE HAVE BEEN NO QUALITY NOTIFICATIONS FOR BATCH NUMBER 0252871 BETWEEN (B)(6) 2020 TO (B)(6) 2022 FOR PART NUMBER 1001-156-004 FOR THIS CONDITION. ADDITIONALLY, BEFORE THE PRODUCT IS SHIPPED TO THE CUSTOMER, A PACKAGING INSPECTION WAS COMPLETED FOR THIS LOT NUMBER AND NO DEFECTS WERE OBSERVED BEFORE SHIPPING TO THE CUSTOMER. DUE TO THIS THE ROOT CAUSE OF THE DEFECT COULD NOT BE DETERMINED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MALE LL ADAPTOR EXPERIENCED PACKAGING ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING AN INCOMING INSPECTION ON 19 JUL 2022, QC FOUND 3 BAGS OF 19469-00 WERE TORN (BOTH LAYERS). THERE ARE A TOTAL OF 2 CARTONS AFFECTED. THERE IS NO ABNORMALITY ON THE CARTON CONDITION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MALE LL ADAPTOR EXPERIENCED PACKAGING ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING AN INCOMING INSPECTION ON (B)(6) 2022, QC FOUND 3 BAGS OF 19469-00 WERE TORN (BOTH LAYERS). THERE ARE A TOTAL OF (B)(4) CARTONS AFFECTED. THERE IS NO ABNORMALITY ON THE CARTON CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2346569 BD MALE LL ADAPTOR INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 0252871

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown