BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM

    MDR report key: 12449332 · Received September 9, 2021

    Report

    Report Number
    9616656-2021-01121
    Event Type
    Malfunction
    Date Received
    September 9, 2021
    Date of Event
    August 12, 2021
    Report Date
    September 23, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903201228
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 9/13/2021. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 0142932. D.4. MEDICAL DEVICE EXPIRATION DATE: 5/31/2025. H.4. DEVICE MANUFACTURE DATE: 8/24/2020. D.4. MEDICAL DEVICE LOT #: 0266084. D.4. MEDICAL DEVICE EXPIRATION DATE: 9/30/2025. H.4. DEVICE MANUFACTURE DATE: 9/22/2020. H.6. INVESTIGATION: CUSTOMER RETURNED (3) OPEN 32GX4MM BD PEN NEEDLES (2 FROM LOT# 0142932 AND 1 FROM LOT# 0266084). CONSUMER REPORTED NO INSULIN FLOW WHEN TAKING INJECTION. ALL 3 RETURNED PEN NEEDLES WERE EXAMINED, AND IT WAS OBSERVED THAT ALL 3 EXHIBITED A BENT NON-PATIENT END (NPE) CANNULA. THE BENT NPE CANNULA WOULD BE THE CAUSE FOR NO FLOW THROUGH THE PEN NEEDLES, HENCE, THE CUSTOMER WOULD THINK THAT THE PEN NEEDLES WERE CLOGGED. SINCE ALL THREE SAMPLES WERE RETURNED AFTER USE, THE PROBABLE CAUSE OF THE BENT NPE CANNULAS IS USER RELATED. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. THE ROOT CAUSE FOR THIS ISSUE IS USER RELATED. THE NPE CANNULAS WERE BENT AFTER THE USER HANDLED THE PEN NEEDLES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD PEN NDL 32G 4MM WAS UNABLE TO DELIVER INSULIN OR MEDICATION AND UNABLE TO PRIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CONSUMER REPORTED NO INSULIN FLOW WHEN TAKING INJECTION SOMETIMES NO INSULIN FLOW WHEN PRIMING. DATE OF EVENT : UNKNOWN. SAMPLES: YES.

    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 1 BD PEN NDL 32G 4MM WAS UNABLE TO DELIVER INSULIN OR MEDICATION AND UNABLE TO PRIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED NO INSULIN FLOW WHEN TAKING INJECTION SOMETIMES NO INSULIN FLOW WHEN PRIMING. DATE OF EVENT : UNKNOWN. SAMPLES : YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1346852 PEN NDL 32G 4MM HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320122 SEE H.10 00382903201228

    Patients

    Seq Age Sex Outcome Treatment
    1