BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEN NDL¿ 29GA SHIELD BULK

    MDR report key: 8428790 · Received March 18, 2019

    Report

    Report Number
    9616656-2019-00254
    Event Type
    Malfunction
    Date Received
    March 18, 2019
    Date of Event
    February 26, 2019
    Report Date
    April 12, 2019
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THREE OPENED 29G X 12.7MM PEN NEEDLE SAMPLES WERE RETURNED FROM LOT NO. 8015906 AND ONE OPENED 29G X 12.7MM PEN NEEDLE SAMPLE WAS RETURNED FROM LOT NO. 7032849, CAT. NO. 320117. MAGNIFIED EXAMINATION WAS CARRIED OUT AND A BROKEN TIP OF THE SHIELD WAS OBSERVED ON ALL FOUR SAMPLES. A LOT HISTORY REVIEW WAS CARRIED OUT FOR BOTH LOTS AND AN NOE WAS RAISED ON LOT. NO. 7032849 FOR A MOULD PART DEFECTIVE NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH LOT. NO. 8015906. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS AND MET REQUIRED ACCEPTANCE LEVELS. UPON START UP A SHORT SHOT OCCURRED, ONE OF THESE SHORTS WAS NOT REMOVED FROM THE CAVITY ALLOWING THE NEXT SHOT TO OVER MOULD AROUND THIS SHOT CAUSING THE HOLE IN SHIELDS AS IDENTIFIED. BASED ON AN EVALUATION OF SEVERITY AND OCCURRENCE IT WAS DETERMINED THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING INSPECTION OF ORDER OF 4 BD PEN NDL¿ 29GA SHIELD BULK WERE MISSING A PIECE OF THE NEEDLE SHIELD.

    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 #: 7032849, MEDICAL DEVICE EXPIRATION DATE: 2022-01-31, DEVICE MANUFACTURE DATE: 2017-02-01; MEDICAL DEVICE LOT #: 8015906, MEDICAL DEVICE EXPIRATION DATE: 2023-01-31, DEVICE MANUFACTURE DATE: 2018-01-15." A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INSPECTION OF ORDER OF 4 BD PEN NDL¿ 29GA SHIELD BULK WERE MISSING A PIECE OF THE NEEDLE SHIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223882 BD PEN NDL¿ 29GA SHIELD BULK PEN NEEDLE FMI BECTON DICKINSON AND CO. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other