BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIAL ADAPTER

    MDR report key: 15573258 · Received October 10, 2022

    Report

    Report Number
    3000223297-2022-00005
    Event Type
    Malfunction
    Date Received
    October 10, 2022
    Date of Event
    December 4, 2022
    Report Date
    December 27, 2022
    Manufacturer
    WEST PHARMA. SERVICES IL, LTD
    Product Code
    LHI
    UDI-DI
    07290108241075
    PMA / PMN Number
    K963583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    WEST IL INVESTIGATED A COMPLAINT RECEIVED BY BAXTER HEALTHCARE CORPORATION REGARDING AN INSECT FOUND ADHERED TO THE INSIDE OF THE SEALED PACKAGING BLISTER OF WEST'S VIAL ADAPTER (VA 20MM ML BLUE SIL - SF) DURING BAXTER'S INSPECTION OF VIAL ADAPTERS. THE REPORTED ISSUE WAS VERIFIED. BATCH RECORDS FOR CATALOG# 8072050 WITH LOT# F645 WERE REVIEWED. IT WAS FOUND THAT THE PRODUCT WAS MANUFACTURED ACCORDING TO RELEVANT PROCEDURES, TESTED BEFORE RELEASE, AND SHIPPED ACCORDING TO SPECIFICATIONS. QC INSPECTIONS INCLUDING VISUAL, IN-PROCESS, AND FINAL INSPECTIONS WERE CONDUCTED ACCORDING TO PROCEDURES. NO ISSUES WERE IDENTIFIED FOR THIS LOT DURING PRODUCTION /PACKAGING. COMPLAINT TRENDS WERE REVIEWED FOR THE PAST THREE (3) YEARS FOR THIS VIAL ADAPTER 20MM PRODUCT FAMILY. NO ISSUES WERE IDENTIFIED DURING THE REVIEW. A REVIEW OF THE MDR TREND FOR THE FOREIGN MATERIAL IDENTIFIED IN THE COMPLAINT WAS ALSO CONDUCTED FOR THE PERIOD OF JUNE 2021 TO NOVEMBER 2022. NO SIGNIFICANT TREND WAS IDENTIFIED DURING THE REVIEW. THERE WERE NO COMPLAINTS FOR THE LAST THREE (3) YEARS IN THE COMPLAINT DATABASE FOR LOT# F645. NINETY (90) RETAINED SAMPLES FROM LOT# F645 WERE INSPECTED FOR THIS ISSUE BY MANUFACTURING QUALITY AND NO ISSUES WERE IDENTIFIED. THE SAMPLE WAS RETURNED TO WEST IL AND INSPECTED BY QUALITY ASSURANCE (QA). AN INSECT WAS FOUND INSIDE OF THE BLISTER PACK. THE ENTOMOLOGICAL ANALYSIS IDENTIFIED THE INSECT AS ARANEAE AGELENIDAE. THE ENTOMOLOGICAL LABORATORIES COULD NOT DETECT THE SPECIES OF THE AGELENIDAE. THE ROOT CAUSE WAS DETERMINED TO BE THE SUB-CONTRACTOR'S PEST CONTROL PROCEDURE AND TRAPS MAPPING WERE INSUFFICIENT AS NO INSECT TRAP WAS LOCATED IN THE RAW MATERIALS ENTRANCE ROOM. AS A RESULT OF THE FINDINGS, THE SUB-CONTRACTOR WILL FUMIGATE AROUND THE BUILDING EVERY 4 MONTHS, ADD AN INSECT CONTROL TRAP IN THE RM ENTRANCE ROOM, AND ADD CONTROLS BY ADDITIONAL SAMPLING FOR BIOLOGICAL CONTAMINATION (INSECT) FOR ALL PRODUCTS MANUFACTURED AND SAMPLING ADDITIONAL PRODUCTS, ACCORDING TO ANSI/ASQ Z1.4 2008 ACCORDING TO AQL-0.01 LEVEL II. AS A RESULT, THE SUPPLIER IMPLEMENTED CORRECTIVE ACTIONS; NO FURTHER ACTIONS ARE CURRENTLY REQUIRED FROM WEST IL.

    Additional Manufacturer Narrative · 0

    THE VIAL ADAPTER IS A SINGLE-USE DEVICE THAT ALLOWS FOR THE TRANSFER OF FLUIDS OUT OF AND INTO DRUG VIALS. THE DEVICE IS A ONE-PIECE POLYCARBONATE MOLDED PART WITH A STANDARD FEMALE OR MALE LUER PORT FOR CONNECTING A SYRINGE. A SUPPLEMENTAL REPORT WILL BE FILED WHEN MORE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    ON (B)(6) 2022, BAXTER HEALTHCARE CORPORATION (BAXTER) CONTACTED (B)(4) TO REPORT A FOREIGN MATERIAL ADHERED TO THE INSIDE OF THE SEALED PACKAGING OF (B)(4) VIAL ADAPTER (CATALOG# 8072050, LOT F645). THIS ISSUE WAS FOUND BY BAXTER ON ONE VIAL ADAPTER DURING THEIR INSPECTION OF 10,900 VIAL ADAPTERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2888722 VIAL ADAPTER VIAL ADAPTER LHI WEST PHARMA. SERVICES IL, LTD 8072050 F645 07290108241075

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown