BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE FILTER BLUNT FILL 18X1-1/2

    MDR report key: 11810590 · Received May 12, 2021

    Report

    Report Number
    1911916-2021-00423
    Event Type
    Malfunction
    Date Received
    May 12, 2021
    Date of Event
    April 13, 2021
    Report Date
    April 21, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    GAA
    UDI-DI
    30382903052111
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    "DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 305211 AND LOT NUMBER 8250854. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NEEDLE FILTER BLUNT FILL 18X1-1/2 WAS CLOGGED DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER "IT WAS REPORTED THAT THE CUSTOMER FELT THE NEEDLE WAS CLOGGED. PER COMPLAINT DETAILS RECEIVED: DURING THE CUSTOMER TRIED TO WITHDRAW THE SOLUTION, FELT THE FILTER NEEDLE WAS CLOGGED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711579 NEEDLE FILTER BLUNT FILL 18X1-1/2 MANUAL SURGICAL INSTRUMENT FOR GENERAL USE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 305211 8250854 30382903052111

    Patients

    Seq Age Sex Outcome Treatment
    1