BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE¿ PEN NEEDLE

    MDR report key: 8620312 · Received May 17, 2019

    Report

    Report Number
    8041187-2019-00385
    Event Type
    Malfunction
    Date Received
    May 17, 2019
    Date of Event
    May 1, 2019
    Report Date
    May 31, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    NSC
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: DHR WAS PERFORMED AND NO QUALITY NOTIFICATION WAS RAISED OR ABNORMALITY THAT COULD HAVE INFLUENCED THE ISSUE. SAMPLES WERE RECEIVED IN A DAMAGED SHELF CARTON CONTAINING A MIX OF DIFFERENT SIZED PEN NEEDLES CONFIRMING THE COMPLAINT. THERE WAS NO BACK TO BACK RUN FOR THE BATCH NUMBERS MIXED HENCE A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD MICRO-FINE¿ PEN NEEDLE CAME WITH A MIX OF PRODUCT TYPES IN A PACK. THIS OCCURRED ON 10 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER HAD BROUGHT IN A BOX OF BD 5MM MICROFINE PEN NEEDLES WHICH HAD SOME 8MM NEEDLES MIXED IN. THERE WERE 2 DIFFERENT BATCH NUMBERS OF THE 8MM NEEDLES - (B)(4). PHARMACY SAID THAT ON LOOKING AT THE DISPENSED HISTORY, THEY HAD NEVER SUPPLIED THE CUSTOMER WITH ANY 8MM PEN NEEDLES.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 MICRO-FINE¿ PEN NEEDLE CAME WITH A MIX OF PRODUCT TYPES IN A PACK. THIS OCCURRED ON 10 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER HAD BROUGHT IN A BOX OF BD 5MM MICROFINE PEN NEEDLES WHICH HAD SOME 8MM NEEDLES MIXED IN. THERE WERE 2 DIFFERENT BATCH NUMBERS OF THE 8MM NEEDLES - 7061494 AND 6032491. PHARMACY SAID THAT ON LOOKING AT THE DISPENSED HISTORY, THEY HAD NEVER SUPPLIED THE CUSTOMER WITH ANY 8MM PEN NEEDLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415375 BD MICRO-FINE¿ PEN NEEDLE PEN NEEDLE NSC BECTON DICKINSON MEDICAL (SINGAPORE) 7122340

    Patients

    Seq Age Sex Outcome Treatment
    1 Other