BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE FILTER BLUNT FILL 18X1-1/2

    MDR report key: 9772166 · Received February 28, 2020

    Report

    Report Number
    1911916-2020-00200
    Event Type
    Malfunction
    Date Received
    February 28, 2020
    Date of Event
    February 24, 2020
    Report Date
    February 25, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    GAA
    UDI-DI
    30382903052111
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: 1 PHOTO WAS PROVIDED. IT SHOWS A PACKAGING BLISTER WITH THE TOP WEB, IT IS TORN ON THE BOTTOM PART OF THE NEEDLE ASSEMBLY; THE PLASTIC NEEDLE HUB IS VISIBLE. IT LOOKS LIKE THE PART WAS OPENED BY PUSHING THE NEEDLE ASSEMBLY AND GETTING TORN THE TOP WEB INSTEAD OF PULLING APART THE BOTTOM-TOP WEB. WHILE THE SYMPTOM IS CONFIRMED; IT IS UNCLEAR HOW THIS DAMAGED HAPPENED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES. INVESTIGATION CONCLUSION: THIS IS THE 1ST COMPLAINT FOR LOT # 8206851 FOR THIS TYPE OF DEFECT OR SYMPTOM. THERE WAS NO DOCUMENTATION FOR THIS TYPE OF DEFECT DURING THE ENTIRE PRODUCTION RUN OF THIS BATCH. ROOT CAUSE DESCRIPTION: UNDETERMINED. RATIONALE: CAPA NOT REQUIRED AT THIS TIME

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF NEEDLE FILTER BLUNT FILL 18X1-1/2 EXPERIENCED A DAMAGED OR OPEN UNIT PACKAGE/SEAL WHERE THE STERILITY OF THE PRODUCT IS COMPROMISED. PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I¿M WRITING BECAUSE A NOTIFICATION ON BATCH 8206851 OF FILTER NEEDLES 18G CODE K272200 HAS BEEN RECEIVED. THE CLAIM IS RELATED TO A TORN NEEDLE POCKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235645 NEEDLE FILTER BLUNT FILL 18X1-1/2 MANUAL SURGICAL INSTRUMENT FOR GENERAL USE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 305211 8206851 30382903052111

    Patients

    Seq Age Sex Outcome Treatment
    1 Other