BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MP VIAL ADAPTER 13 MM

    MDR report key: 20136052 · Received September 4, 2024

    Report

    Report Number
    3000223297-2024-00004
    Event Type
    Malfunction
    Date Received
    September 4, 2024
    Date of Event
    July 24, 2024
    Report Date
    February 10, 2025
    Manufacturer
    WEST PHARMA SERVICES IL, LTD
    Product Code
    LHI
    UDI-DI
    07290108240199
    PMA / PMN Number
    K130179
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT IS CURRENTLY BEING INVESTIGATED BY MANUFACTURER. DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. HOWEVER, A PHOTOGRAPH WAS PROVIDED WITH VISIBLE DEFORMITIES OF THE PACKAGED DEVICE. UPON COMPLETION OF THE INVESTIGATION AND IF ADDITIONAL INFORMATION IS PROVIDED FROM THE MANUFACTURER'S CUSTOMER A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    A REVIEW OF BATCH RECORDS FOR LOT#J792 REVEALED NO NON-CONFORMANCE. ALL QC INSPECTIONS WERE CONDUCTED ACCORDING TO PROCEDURES, NO OTHER ISSUES WERE IDENTIFIED. ACCORDING TO THE MANUFACTURER'S RECORDS, LOT#J792 WAS MANUFACTURED ACCORDING TO RELEVANT PROCEDURES, TESTED BEFORE RELEASE, PACKED AND SHIPPED ACCORDING TO SPECIFICATIONS. COMPLAINTS DATABASE OF THE LAST THREE YEARS WAS REVIEWED; ONE JUSTIFIED COMPLAINT WAS IDENTIFIED FOR THIS LOT REGARDING SHIPPING DAMAGE. RETAINED SAMPLES FROM LOT#J793 WERE 100% VISUALLY INSPECTED BY THE CONTRACT MANUFACTURER - NO FINDINGS WERE OBSERVED. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER'S PHARMACEUTICAL CUSTOMER REVEALED, (B)(4) INSPECTED Q-CAP DEVICES WERE FOUND BENT AND OTHERS WERE PARTIALLY OPEN. ACCORDING TO THE SUB-CONTRACTORS' REVIEW OF STERILIZATION RECORDS, NO ISSUES WERE NOTICED FOR LOT# J972. NO SAMPLES WERE RETURNED TO THE MANUFACTURER. HOWEVER, PER THE OBTAINED PICTURES, THE Q-CAP DEVICES WERE DETECTED WITH DEFORMED AD OPEN BLISTERS AND THE ISSUE WAS VERIFIED. ACCORDING TO AVAILABLE DATA, IT IS LIKELY THAT LOT# J792 WAS NOT EXPOSED TO HIGH TEMPERATURES DURING THE MANUFACTURING AND OR STERILIZATION PROCESS. THE MANUFACTURER IS UNABLE TO FULLY MONITOR THE CONDITIONS THE PRODUCTS ARE EXPOSED TO WHILE UNDER SERVICE PROVIDERS SUCH AS COURIERS AND TRANSPORTATION CONTRACTORS. HENCE, THIS ISSUE LIKELY OCCURRED DURING SHIPMENT OF LOT# J792. THIS IS DUE TO INSUFFICIENT TEMPERATURE MONITORING OVER THE DOOR TO DOOR SHIPMENT PROCESS, WHICH IS THE MANUFACTURER'S RESPONSIBILITY.

    Additional Manufacturer Narrative · 0

    UNIQUE DEVICE IDENTIFIER (UDI) # CORRECTED. COMPLAINT IS CURRENTLY BEING INVESTIGATED BY MANUFACTURER. UPON COMPLETION OF THE INVESTIGATION AND IF ADDITIONAL INFORMATION IS PROVIDED FROM THE MANUFACTURER'S CUSTOMER A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON 30JUL2024, FERRING PHARMACEUTICALS INC., CONTACTED WEST PHARMA. SERVICES, IL LTD. (WEST IL), TO REPORT THAT TWO (2) BATCHES OF MP VIAL ADAPTERS 13MM, DID NOT MEET THE QUALITY CONTROL INCOMING SPECIFICATION AT FERRING PHARMACEUTICALS AND WERE REJECTED DUE TO OPEN AND DEFORMED BLISTERS OF THE PRIMARY PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918762 MP VIAL ADAPTER 13 MM MP VIAL ADAPTER 13 MM LHI WEST PHARMA SERVICES IL, LTD J792 07290108240199

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown