BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 26X3/8 IB

    MDR report key: 9993359 · Received April 23, 2020

    Report

    Report Number
    1911916-2020-00405
    Event Type
    Malfunction
    Date Received
    April 23, 2020
    Date of Event
    March 21, 2020
    Report Date
    April 14, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051107
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. BASED ON NO SAMPLE, THE INVESTIGATION CONCLUDED, BD WAS NOT ABLE TO VERIFY THE INDICATED FAILURE. 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 2ND COMPLAINT FOR LOT # 9212458 FOR THIS TYPE OF DEFECT OR SYMPTOM. PREVIOUS COMPLAINT (B)(4). THERE WAS NO DOCUMENTATION FOR THIS TYPE OF DEFECTS DURING THE ENTIRE PRODUCTION RUN OF THIS BATCH #. ROOT CAUSE DESCRIPTION: UNDETERMINED. THE CUSTOMER STATES THAT IS USING THE NEEDLE MULTIPLE TIMES; IT SHOULD ONLY BE USED ONCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NEEDLE ISSUE OCCURRED DURING USE WITH A NEEDLE 26X3/8 IB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT WAS REPORTED THAT CUSTOMER THINKS NEEDLE WAS CREATING TOO LARGE OF A HOLE IN WHITE FILL PORT. DESCRIPTION OF ISSUE: CUSTOMER THINKS THERE WAS AN ISSUE WITH THE NEEDLE BECAUSE TWO CARTRIDGES IN A ROW LEAKED FROM USING THIS SAME NEEDLE. CUSTOMER CHANGED OUT NEEDLE AND SUCCESSFULLY FILLED THIRD CARTRIDGE WITH INSULIN. CUSTOMER THINKS NEEDLE WAS CREATING TOO LARGE OF A HOLE IN WHITE FILL PORT WHICH CAUSE THE CARTRIDGES TO LEAK. 2 OCCURRENCES WITH SAME NEEDLE. 26 G, 3/8¿ NEEDLE ¿ 305110. PRODUCT LOT NUMBER: 9212458. DID ISSUE CAUSE ANY INJURY? NO. MEDICAL INTERVENTION NEEDED? NO." 2 OCCURRENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456399 NEEDLE 26X3/8 IB HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 305110 9212458 30382903051107

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other