BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIAL ADAPTER

    MDR report key: 16052153 · Received December 27, 2022

    Report

    Report Number
    3000223297-2022-00006
    Event Type
    Malfunction
    Date Received
    December 27, 2022
    Date of Event
    May 30, 2022
    Report Date
    December 27, 2022
    Manufacturer
    WEST PHARMA. SERVICES IL, LTD
    Product Code
    LHI
    PMA / PMN Number
    K963583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    WEST PHARMA. SERVICES IL LTD. (WEST) INVESTIGATED A COMPLAINT RECEIVED REGARDING 3 VIAL ADAPTERS THAT WERE DETECTED DURING KITTING WITH A FRACTURE OVER THE BLISTER. THE RETURNED SAMPLES WERE RECEIVED ON 15JUNE2022 AND WERE INSPECTED. IT WAS DETERMINED THAT TWO SAMPLES WERE DETECTED WITH A FRACTURE IN THE FLANGE AREA AND ONE SAMPLE WAS DETECTED WITH A FRACTURE IN THE PLUG AREA -OPEN BLISTER. SAMPLE WITH A FRACTURE IN THE PLUG AREA COULD NOT BE SIMULATED. WEST SENT A FORMAL REQUEST OF INVESTIGATION TO THE SUPPLIER. WEST, FOUND THAT THE ROOT CAUSE WAS A FRACTURE WHICH OCCURRED AS A RESULT OF AN ISSUE WITH THE RAW MATERIAL. SINCE THE PRODUCTS WERE VISUALLY INSPECTED WITH NO EVIDENCE OF ANY PRODUCT WITH FRACTURE BLISTERS IN THE PLUG AREA, THIS ISSUE IS CONSIDERED AN ISOLATED CASE.

    Description of Event or Problem · 0

    ON (B)(6) 2022, FERROSAN MEDICAL DEVICES A/S CONTACTED WEST IL TO REPORT THAT THREE VIAL ADAPTER (VA) 20MM FLL, BATCH 265307/ LOT F420, WERE SCRAPPED DUE TO INCOMPLETE BLISTER PACK SEALS DURING THEIR KITTING PROCESS. THE REPORTED ISSUE WAS DETECTED BY MANUAL VISUAL CONTROL; NO MACHINES WERE INVOLVED IN THE PROCESS OF HANDLING THE VIAL ADAPTERS. THE COMPLAINT WAS RE-EVALUATED AND DEEMED AS REPORTABLE BASED ON A CLINICAL IMPACT ASSESSMENT DATED 12/01/2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444390 VIAL ADAPTER VIAL ADAPTER LHI WEST PHARMA. SERVICES IL, LTD 8072043 F420

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown