BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM HP

    MDR report key: 11566553 · Received March 24, 2021

    Report

    Report Number
    9616656-2021-00322
    Event Type
    Malfunction
    Date Received
    March 24, 2021
    Date of Event
    March 1, 2021
    Report Date
    May 10, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903205509
    PMA / PMN Number
    K182320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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: 4/30/2021. H.6. INVESTIGATION: CUSTOMER RETURNED (5) USED 32GX4MM BD PEN NEEDLES WITHOUT TEAR DROP LABELS OR INNER SHIELDS ATTACHED. THE CONSUMER REPORTED NEEDLE CLOG DURING INJECTION. ALL 5 PEN NEEDLES WERE EXAMINED, AND IT WAS OBSERVED THAT ALL 5 EXHIBITED A BENT NON-PATIENT END (NPE) CANNULA. NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED. THE BENT NPE CANNULAS WOULD BE THE CAUSE FOR NO FLOW THROUGH THE PEN NEEDLES, HENCE, THE CUSTOMER WOULD THINK THE PEN NEEDLES WERE CLOGGED, AS REPORTED. SINCE ALL 5 SAMPLES WERE RETURNED AFTER USE, AND NO MANUFACTURING DEFECTS WERE OBSERVED, THE PROBABLE CAUSE OF THE BENT NPE CANNULAS IS USER ERROR WHEN ATTACHING THE PEN NEEDLES TO A PEN INJECTOR. 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PEN NDL 32G 4MM HP WAS UNABLE TO DELIVER INSULIN/MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUME REPORTED NEEDLE CLOG DURING INJECTION. CONSUMER DOES NOT RE-USE. LOT #: 0203719. CATALOG #: 320550. DATE OF EVENT: UNKNOWN.

    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 THE PEN NDL 32G 4MM HP WAS UNABLE TO DELIVER INSULIN/MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUME REPORTED NEEDLE CLOG DURING INJECTION. CONSUMER DOES NOT RE-USE. LOT #: 0203719, CATALOG #: 320550, DATE OF EVENT: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456219 PEN NDL 32G 4MM HP PEN NEEDLE FMI BECTON DICKINSON AND CO. 320550 0203719 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1