BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 26X1/2 RB

    MDR report key: 11270171 · Received February 2, 2021

    Report

    Report Number
    1911916-2021-00083
    Event Type
    Malfunction
    Date Received
    February 2, 2021
    Date of Event
    January 7, 2021
    Report Date
    January 26, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    00382903051113
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305111 AND LOT NUMBER 9193541. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED DEFECT. TO AID IN THE INVESTIGATION, TWO HUNDRED SEVENTEEN PHYSICAL SAMPLES AND FOUR PHOTOS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE SAMPLES CAME IN SEALED PACKAGE BLISTERS. A VISUAL INSPECTION WAS PERFORMED WITH A 10X MAGNIFIERS LENS AND NO EMBEDDED DEGRADED RESIN OR ANY OTHER DEFECT OR IMPERFECTION WAS OBSERVED. ALL THE PHOTOS SHOW A NEEDLE ASSEMBLY WITH THE PLASTIC SHIELD. ONE PHOTO SHOWS A PLASTIC SHIELD WITH EMBEDDED FOREIGN MATTER. THE REMAINING THREE PHOTOS SHOW THE NEEDLE HUB WITH EMBEDDED FOREIGN MATTER. INVESTIGATION CONCLUSION: BASED ON THE INVESTIGATION WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. THERE ARE QUALITY CONTROLS CURRENTLY IN PLACE TO DETECT THIS TYPE OF DEFECT DURING THE PRODUCTION PROCESS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ROOT CAUSE DESCRIPTION: IT COULD BE POSSIBLE FOR THIS DEFECT TO OCCUR INTERMITTENTLY OR DURING THE STARTUP OF THE MOLDING PROCESS. DEGRADED RESIN INHERENTLY BUILDS UP IN THE HOT-RUNNER SYSTEM, CAN BREAK LOOSE AND BE MOLDED INTO COMPONENTS. RATIONALE: FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEEDLE 26X1/2 RB HAD STAINS IN THE CAPS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305111, BATCH NO: 9193541. IT WAS REPORTED STAINS IN THE CAPS. VERBATIM: PER CUSTOMER'S E-MAIL SENT TO US ON (B)(6) 2021. WHAT IS THE DATE OF EVENT? THE ITEMS WERE IDENTIFIED ON (B)(6) 2021. WAS ANYONE HURT? NOT AT THIS MOMENT, THIS WAS IDENTIFIED IN THE PRODUCTION LINE DO YOU HAVE PATIENT IDENTIFIERS? NOT APPLICABLE, IDENTIFIED IN THE PRODUCTION LINE. HOW MANY NEEDLES WERE WITH STAINS? THE CUSTOMER SORTED 1000 UNITS AND FOUND 220 WITH ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163285 NEEDLE 26X1/2 RB HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 9193541 00382903051113

    Patients

    Seq Age Sex Outcome Treatment
    1