BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 30X1/2 RB

    MDR report key: 11202262 · Received January 20, 2021

    Report

    Report Number
    1911916-2021-00039
    Event Type
    Malfunction
    Date Received
    January 20, 2021
    Date of Event
    December 28, 2020
    Report Date
    January 18, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051060
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. (B)(4). INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 9030555. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS INCIDENT, ONE SHELF BOX WITH 100 PHYSICAL SAMPLES WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE SHELF BOX HAS BEEN ALREADY OPENED AND IT IS LABELED AS LOT# 9030555. A VISUAL INSPECTION WAS PERFORMED. THE 50 SAMPLES ARE LABELED WITH THE LOT# 903055 AND ANOTHER 50 SAMPLES ARE LABELED WITH THE LOT# 9163857. INVESTIGATION CONCLUSION: OUR QUALITY TEAM WILL CONTINUE TO MONITOR THE MANUFACTURING PROCESS FOR THIS DEFECT AND OTHER EMERGING TRENDS. ROOT CAUSE DESCRIPTION: THE CAUSE FOR THIS DEFECT WAS NOT ABLE TO BE DETERMINED AND IT IS UNCLEAR WHERE THE MIX OCCURRED. RATIONALE: FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEEDLE 30X1/2 RB CAME WITH MIXED LOTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305136, BATCH NO: 9030555. IT WAS REPORTED THAT THERE ARE MIXED LOTS IN THE BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100856 NEEDLE 30X1/2 RB HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 305106 9030555 30382903051060

    Patients

    Seq Age Sex Outcome Treatment
    1