BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEN NDL 32G 4MM

    MDR report key: 12632395 · Received October 14, 2021

    Report

    Report Number
    8041187-2021-00903
    Event Type
    Malfunction
    Date Received
    October 14, 2021
    Date of Event
    September 16, 2021
    Report Date
    October 18, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-10-08. H6: INVESTIGATION SUMMARY CUSTOMER RETURNED (9) 32GX4MM BD PEN NEEDLES FROM LOT# 0073558 (7 SEALED AND 2 OPENED). THE CONSUMER STATED NO INSULIN FLOW WHEN PRIMING. ALL 9 RETURNED PEN NEEDLES WERE EXAMINED, THEN TESTED FOR FLOW USING A TEST PEN INJECTOR. ALL 9 PEN NEEDLES WERE ABLE TO EXPEL PROPERLY. NO DEFECTS WERE OBSERVED. PEN NEEDLE DHR BATCH 0073558 WAS REVIEWED. THE BATCH NUMBER WAS BUILT WITH PEN NEEDLE ASSEMBLY LINE IN OCT 2020. REVIEW OF THE DHR REVEALED ALL REQUIRED CHALLENGES SAMPLES AND TESTING WAS PERFORMED PER SPECIFICATION IN ACCORDANCE WITH THE IN-PROCESS SAMPLING PLANS. NO QUALITY NOTIFICATION WAS RAISED ON PAST 12 MONTHS ON SIMILAR NON-CONFORMANCE. BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 10 BD PEN NDL 32G 4MM WERE UNABLE TO PRIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER STATED NO INSULIN FLOW WHEN PRIMING 10 PEN NEEDLES. DATE OF EVENT : UNKNOWN. SAMPLES : AVAILABLE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 10 BD PEN NDL 32G 4MM WERE UNABLE TO PRIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CONSUMER STATED NO INSULIN FLOW WHEN PRIMING 10 PEN NEEDLES. DATE OF EVENT: UNKNOWN. SAMPLES: AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1528295 BD PEN NDL 32G 4MM HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 0073558

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown