BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIXJECT 20MM W/20G X 1.5'' NEEDLE

    MDR report key: 17373215 · Received July 21, 2023

    Report

    Report Number
    3000223297-2023-00011
    Event Type
    Malfunction
    Date Received
    July 21, 2023
    Date of Event
    June 22, 2023
    Report Date
    May 3, 2024
    Manufacturer
    WEST PHARMA. SERVICES IL, LTD
    Product Code
    LHI
    UDI-DI
    07290108240832
    PMA / PMN Number
    K963583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2023, THE CUSTOMER, GP PHARM., CONTACTED WEST PHARMA. SERVICES, IL LTD. (WEST IL) WITH ADDITIONAL INFORMATION. IT WAS REPORTED THAT DURING PACKAGING AND QUALITY CONTROL OF THE MIXJECT 20MM W/20G X 1.5" NEEDLE, LOT F967, TWO ADDITIONAL UNITS WERE FOUND WITH FOREIGN MATERIAL INSIDE THE SEALED AND PACKAGED PRODUCTS. WEST IL, IS CURRENTLY INVESTIGATING THIS COMPLAINT. THE DEVICES HAVE NOT YET BEEN RETURNED TO WEST IL FOR EVALUATION. HOWEVER, PHOTOGRAPHS WERE PROVIDED TO WEST IL WITH VISIBLE FOREIGN MATERIAL AS REPORTED INSIDE OF THE PACKAGED DEVICES. 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 IL IS CURRENTLY INVESTIGATING THIS COMPLAINT. THE DEVICE HAS NOT YET BEEN RETURNED TO WEST IL FOR AN EVALUATION. HOWEVER, A PHOTOGRAPH WAS PROVIDED TO WEST IL BY THE CUSTOMER WITH A VISIBLE PARTICLE AS REPORTED INSIDE OF THE PACKAGED DEVICE. 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

    RETAINED SAMPLES FROM LOT#: F967 WERE 100% INSPECTED BY THE CONTRACT MANUFACTURER, NO ISSUES WERE OBSERVED. AN OFFICIAL SUPPLIER COMPLAINT WAS SENT TO THE CONTRACT MANUFACTURER. ACCORDING TO THE CONTRACT MANUFACTURER'S INVESTIGATION, ONE PRODUCT WAS OBSERVED WITH A YELLOW FREE PARTICLE INSIDE OF THE PRODUCT BLISTERS. IT IS MOST LIKELY THAT THE FREE PARTICLE WAS ADHERED TO THE OPENED PRODUCT DURING THE MANUAL OPERATION AT THE SEALING STATION, OR IT WAS ADHERED FROM ONE OF THE SUPPLIED THE RAW MATERIALS. REGARDING THE TWO PRODUCTS WITH FOREIGN MATTER ON THE CANNULA, THE MOST PROBABLE ROOT CAUSE WAS DUE TO INSUFFICIENT PROCESS AND PROCEDURE TO AVOID FOREIGN MATERIAL ADHERING TO THE PRODUCT. ADDITIONALLY, THE RETURNED SAMPLES WERE TESTED TO IDENTIFY THE FOREIGN MATERIALS. ACCORDING TO THE TEST RESULTS, ONE MATERIAL WAS IDENTIFIED AS POLYPROPYLENE, AND THE SECOND MATERIAL WAS IDENTIFIED AS SILICON RUBBER. CORRECTIVE ACTIONS WERE ISSUED BY THE CONTRACT MANUFACTURER AND THE NEEDLE SUPPLIER TO UPDATE THEIR PROCEDURES IN EFFORT TO REDUCE ENVIRONMENTAL EXPOSURE TO THE PRODUCTS. NO OTHER SIMILAR JUSTIFIED COMPLAINTS WERE FOUND. DEVICE MANUFACTURING DATE UPDATED TO 12DEC2022. NO FURTHER CORRECTIVE ACTION IS REQUIRED BY WEST IL.

    Additional Manufacturer Narrative · 0

    A PRELIMINARY INVESTIGATION WAS PERFORMED BY WEST IL. ACCORDING TO PRODUCTION RECORDS REVIEW, LOT# F967 WAS MANUFACTURED ACCORDING TO RELEVANT PROCEDURES, TESTED BEFORE RELEASE, SHIPPED ACCORDING TO SPECIFICATIONS, AND SEALED BY A NELIPAK SEALING MACHINE. BATCH RECORD FOR LOT# F967 WAS REVIEWED AND NO NCM'S WERE FOUND. ALL QC INSPECTIONS WERE CONDUCTED ACCORDING TO PROCEDURES DURING PRODUCTION, NO ISSUES WERE NOTICED. THE INCOMING INSPECTION RECORDS OF THE TYVEK AND BLISTER USED FOR THE MANUFACTURING OF LOT# F967 WERE REVIEWED, NO ISSUES WERE NOTICED. THE INCOMING INSPECTION RECORDS OF THE NEEDLES USED FOR THE MANUFACTURING OF LOT F967 WERE REVIEWED. NO NCM WERE NOTICED RELATED TO THE REPORTED ISSUE AND NO OTHER ISSUES WERE NOTICED. THREE SAMPLES WERE RETURNED AND RECEIVED AT WEST IL AND WERE INSPECTED. IN A VISUAL INSPECTION, THE FIRST SAMPLE HAD A FREE PARTICLE WAS OBSERVED INSIDE THE BLISTER. THE SECOND SAMPLE, A FIBER WAS NOTICED OVER THE CANNULA. THE THIRD SAMPLE, A PARTICLE WAS NOTICED OVER THE CANNULA. AN OFFICIAL SUPPLIER COMPLAINT WAS SENT TO THE CONTRACT MANUFACTURER WITH A REQUEST FOR AN INVESTIGATION ON THE SAMPLE WITH THE YELLOW PARTICLE. ACCORDING TO THE CONTRACT MANUFACTURER PRELIMINARY INVESTIGATION, BATCH RECORDS WERE REVIEWED FOR THIS LOT, DURING THE MANUFACTURING PROCESS 5,250 PRODUCTS WERE INSPECTED, NO PRODUCTS WERE FOUND WITH ANY FOREIGN PARTICLES. FOR THE FINAL INSPECTION, 5,075 PRODUCTS WERE INSPECTED, AND NONE WERE FOUND WITH ANY FOREIGN PARTICLES. THIS LOT WAS SEALED ON A SEMI-AUTOMATIC NELIPAK SEALING MACHINE, WHILE THE BLISTER WITH THE PRODUCT AND THE TYVEK ARE MANUALLY PLACED IN THIS MACHINE FOR THE SEALING PROCESS. ACCORDING TO THE CHARACTERISTICS OF THE YELLOW PARTICLE INSPECTED BY AN OGP MAGNIFICATION X80, THE PARTICLE WAS IDENTIFIED AS A PART OF THE PLASTIC NEEDLE HUB. REGARDING THE TWO ADDITIONAL SAMPLES WITH FOREIGN MATTER SEEN ON THE CANNULA, AN OFFICIAL SUPPLIER COMPLAINT WAS SENT TO THE NEEDLE SUPPLIER. ACCORDING TO THE NEEDLE SUPPLIER REPORT, PRODUCTION RECORDS WERE REVIEWED, NO DEVIATION WAS INDICATED. RETAINED SAMPLES WERE CHECKED, AND NO DEVIATIONS WERE FOUND. A FOLLOW UP REPORT WILL BE SUBMITTED UPON RECEIPT OF THE FINALIZED REPORTS INCLUDING SAMPLES ANALYSIS FROM BOTH SUPPLIERS.

    Description of Event or Problem · 0

    THE CUSTOMER, GP PHARM, CONTACTED WEST PHARMA. SERVICES, IL LTD. (WEST IL) ON 22JUN2023 TO REPORT THAT DURING PACKAGING AND QUALITY CONTROL OF BATCH 230173, LOT F967, ONE UNIT OF THE MIXJECT 20MM W/20G X 1.5" NEEDLE WAS FOUND WITH A PARTICLE INSIDE OF THE PACKAGED DEVICE. THE EVENT WAS DISCOVERED PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1608387 MIXJECT 20MM W/20G X 1.5'' NEEDLE MIXJECT 20MM W/20G X 1.5'' NEEDLE LHI WEST PHARMA. SERVICES IL, LTD 9070103 F967 07290108240832

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown