BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 25X1-1/2 RB NS

    MDR report key: 8541795 · Received April 23, 2019

    Report

    Report Number
    1911916-2019-00404
    Event Type
    Malfunction
    Date Received
    April 23, 2019
    Date of Event
    April 4, 2019
    Report Date
    May 1, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: FIVE PHOTOS WERE PROVIDED. FROM THE PHOTOS IT IS NOTED THAT THE FINISHING ON THE NEEDLES HAS SOME VARIATION IN COLOR. FAILURE MODE IS VERIFIED HOWEVER ROOT CAUSE CANNOT BE DETERMINED BASED ON THE PHOTOS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 10,000 NEEDLE 25X1-1/2 RB NS EXPERIENCED FOREIGN MATTER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 303018, BATCH NO. 7163807 AND 7144566. IT WAS REPORTED THE NEEDLES ARE DISCOLORED. WE HAVE SOME 303018 PRODUCT IN STOCK WITH DISCOLORATION. IT APPEARS THAT THE NEEDLE IS SMOKED, GIVING A DARK METALLIC DISCOLORATION. FOLLOWING ARE AFFECTED LOTS/QUANTITIES: COMPONENT, LOT#, P.O. QUANTITY. 303018, 7163807, 956518, 5000. 303018, 7144566, 950538, 5000.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EVALUATED BY MFR: A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7163807, MEDICAL DEVICE EXPIRATION DATE: 2022-05-31, DEVICE MANUFACTURE DATE: 2017-06-12. MEDICAL DEVICE LOT #: 7144566, MEDICAL DEVICE EXPIRATION DATE: 2022-05-31, DEVICE MANUFACTURE DATE: 2017-05-24.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 10,000 NEEDLE 25X1-1/2 RB NS EXPERIENCED FOREIGN MATTER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 303018, BATCH NO. 7163807 AND 7144566. IT WAS REPORTED THE NEEDLES ARE DISCOLORED. WE HAVE SOME 303018 PRODUCT IN STOCK WITH DISCOLORATION. IT APPEARS THAT THE NEEDLE IS SMOKED, GIVING A DARK METALLIC DISCOLORATION. FOLLOWING ARE AFFECTED LOTS/QUANTITIES: COMPONENT, LOT#, P.O., QUANTITY: 303018, 7163807, 956518, 5000. 303018, 7144566, 950538, 5000.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335244 NEEDLE 25X1-1/2 RB NS HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other