BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MP VIAL ADAPTER 13MM

    MDR report key: 17663873 · Received August 31, 2023

    Report

    Report Number
    3000223297-2023-00014
    Event Type
    Malfunction
    Date Received
    August 31, 2023
    Date of Event
    August 2, 2023
    Report Date
    January 18, 2024
    Manufacturer
    WEST PHARMA. SERVICES IL, LTD
    Product Code
    LHI
    UDI-DI
    07290108240139
    PMA / PMN Number
    K130179
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    WEST IL IS CURRENTLY INVESTIGATING THIS COMPLAINT. THE DEVICE HAS NOT BEEN RETURNED TO WEST IL FOR AN EVALUATION. HOWEVER, A PHOTOGRAPH WAS PROVIDED TO WEST IL WHICH SHOWS THE DEFORMED PRODUCTS AS REPORTED. UPON COMPLETION OF THE WEST IL INVESTIGATION AND IF ADDITIONAL INFORMATION IS PROVIDED FROM THE CUSTOMER, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    WEST PHARMA SERVICES IL (WEST IL) INVESTIGATED A COMPLAINT RECEIVED BY FERRING PRODUCTION INC. US, REGARDING 13 BOXES OF THE MP VIAL ADAPTER 13MM SIL FLL - VF, LOT J075, FOUND TO HAVE DAMAGED PRIMARY PACKAGING ON ALL INSPECTED SAMPLES. THE RETURNED SAMPLES WERE RECEIVED AT WEST IL, ON (B)(6) 2023, AND WERE INSPECTED. FIVE PRODUCTS WERE DETECTED IN THE Q-CAP BOX WITH DEFORMED BLISTERS, AND 2 PRODUCTS OUT OF 5 WERE DETECTED TO HAVE BLISTERS THAT WERE OPENED. ACCORDING TO THE CUSTOMER, MULTIPLE BOXES WERE REVIEWED AND SIMILAR ISSUE WERE FOUND IN DIFFERENT SHIPPER BOXES. WEST IL PERFORMED AN INVESTIGATION TO INCLUDE BOTH OUTER AND INDIVIDUAL CATALOG AND LOT NUMBERS OF THE MP VIAL ADAPTER 13MM FLL- VF. MP VIAL ADAPTER 13MM FLL- VF 5 PACK Q-CAP, CAT#8070150, LOT#J073 (OUTER PACKAGING MANUFACTURING DATE:(B)(6) 2023) AND MP VIAL ADAPTER 13MM FLL - VF, CAT# 8070142, LOT#J075 (INDIVIDUAL PACKAGING). CATALOG# 8070150 LOT# J073 IS PACKAGED FOR THE CUSTOMER, FERRING PRODUCTION INC. US. ACCORDING TO WEST IL RECORDS, LOT#J073 WAS MANUFACTURED ACCORDING TO RELEVANT PROCEDURES, TESTED BEFORE RELEASE, PACKED, AND SHIPPED ACCORDING TO SPECIFICATIONS. AN OFFICIAL SUPPLIER COMPLAINT WAS SENT TO THE CONTRACT MANUFACTURER 3BY WITH A REQUEST FOR INVESTIGATION. ACCORDING TO THE CONTRACT MANUFACTURER 3BY REPORT, NO ISSUES WERE FOUND WITH THEIR PACKAGING AND INSPECTION PROCESS. AN OFFICIAL SUPPLIER COMPLAINT WAS THEN SENT TO THE SHIPPING VENDOR, DHL WITH A REQUEST FOR INVESTIGATION. ACCORDING TO THE CONTRACT MANUFACTURER DHL REPORT, ALTHOUGH EXTERNAL DAMAGE TO THE SHIPMENT IS NOT AN INDICATION FOR HIGH TEMP EXPOSURE, THE TEMPERATURE MAY NOT AFFECT THE PACKAGING, BUT CAN AFFECT THE PRODUCTS SEALING IN CASE OF EXPOSURE TO TEMPERATURE ABOVE 70°C WHICH MAY LEAD TO BLISTER DEFORMATION AND/OR DAMAGED SEALING. THE RETURNED SAMPLES WERE RECEIVED AT WEST IL, ON (B)(6) 2023, AND WERE INSPECTED. FIVE PRODUCTS WERE DETECTED IN Q-CAP BOX WITH DEFORMED BLISTERS AND 2 PRODUCTS OUT OF 5 WERE DETECTED TO HAVE BLISTERS THAT WERE OPENED. RETAINED SAMPLES WERE VISUALLY INSPECTED FOR BOTH LOTS J075 AND J073 AND NO ISSUES WERE NOTICED. ACCORDING TO AVAILABLE DATA, IT IS MOST LIKELY THAT LOT#J075 WAS NOT EXPOSED TO HIGH TEMPERATURE DURING DEVICE MANUFACTURE OR STERILIZATION. HENCE, LOT#J075 WAS MOST LIKELY EXPOSED TO HIGH TEMPERATURE DURING SHIPMENT OF LOT #J073 WHICH IS THE RESPONSIBILITY OF WEST IL UNTIL THE SHIPMENT ARRIVES TO THE CUSTOMER. THE SHIPPING VENDOR HAS NO SPECIFICATIONS FOR STORAGE AND SHIPPING CONDITIONS, ONLY TO "SHIP AND STORE AT ROOM TEMPERATURE, PROTECT FROM SUN LIGHT." THEREFORE, THE ROOT CAUSE OF THIS EVENT, IS DUE TO INSUFFICIENT DEFINITION FOR STORAGE AND SHIPPING CONDITIONS OF THE FINAL GOODS UNDER WEST IL RESPONSIBILITY. IN ADDITION, NO CURRENT CONTROL EXISTS FOR THE REQUIREMENT TO "AVOID DIRECT SUN LIGHT" DURING STORAGE, SHIPMENT, AND TRANSPORTATION OF THE PACKED PRODUCTS BEFORE STERILIZATION AND FOR FINAL GOODS. WEST IL HAS INITIATED A CORRECTIVE ACTION TO ADDRESS APPROPRIATE STORAGE AND SHIPPING CONDITIONS DEFINITION FOR PACKED PRODUCTS BEFORE STERILIZATION AND FOR FINAL GOODS.

    Description of Event or Problem · 0

    ON (B)(6) 2023, THE CUSTOMER FERRING PRODUCTION INC. US, CONTACTED WEST PHARMA. SERVICES, IL LTD. (WEST IL), TO REPORT THAT UPON QUALITY CONTROL, 13 BOXES OF THE MP VIAL ADAPTER 13MM, LOT J075, WERE FOUND TO HAVE DAMAGED PRIMARY PACKAGING ON ALL INSPECTED SAMPLES. THE EVENT WAS DISCOVERED PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1390205 MP VIAL ADAPTER 13MM MP VIAL ADAPTER 13MM LHI WEST PHARMA. SERVICES IL, LTD J075 07290108240139

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown