BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ BLUNT PLASTIC CANNULA

    MDR report key: 9360325 · Received November 22, 2019

    Report

    Report Number
    1911916-2019-01237
    Event Type
    Malfunction
    Date Received
    November 22, 2019
    Date of Event
    November 4, 2019
    Report Date
    December 5, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903033455
    PMA / PMN Number
    K974363
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: TWO PHOTOS WERE PROVIDED. THEY ARE SHOWING THE TOP WEB WITH THE GRAPHICS. ONE HAS THE PREVIOUS GRAPHICS (MARKED WITH A HANDWRITTEN TEXT AS RETAIN) AND THE OTHER ONE HAS THE NEW GRAPHICS WITH THE UDI 2.0. BOTH ARE ACCORDING TO THE PRODUCTS SPECIFICATIONS EFFECTIVE AT THE TIME THEY WERE MANUFACTURED. FAILURE MODE COULD NOT BE VERIFIED. 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 BD¿ BLUNT PLASTIC CANNULA HAD INCORRECT LABEL INFORMATION. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 303345; BATCH NO.: 9206192, 9162554. IT WAS REPORTED THAT THE PAPER LABEL ON THE BLISTERPACK IS DIFFERENT FROM PREVIOUS LOTS.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9206192. MEDICAL DEVICE EXPIRATION DATE: 2024-07-31. DEVICE MANUFACTURE DATE: 2019-07-25. MEDICAL DEVICE LOT #: 9162554. MEDICAL DEVICE EXPIRATION DATE: 2024-08-31. DEVICE MANUFACTURE DATE: 2019-06-11. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD¿ BLUNT PLASTIC CANNULA HAD INCORRECT LABEL INFORMATION. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 303345 BATCH NO.: 9206192, 9162554. IT WAS REPORTED THAT THE PAPER LABEL ON THE BLISTERPACK IS DIFFERENT FROM PREVIOUS LOTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1160941 BD¿ BLUNT PLASTIC CANNULA HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL SEE H.10 30382903033455

    Patients

    Seq Age Sex Outcome Treatment
    1 Other