BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM PRO

    MDR report key: 12425562 · Received September 3, 2021

    Report

    Report Number
    9616656-2021-01092
    Event Type
    Malfunction
    Date Received
    September 3, 2021
    Date of Event
    August 6, 2021
    Report Date
    August 13, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903205509
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: EXEC SUMMARY - SAMPLES WERE RECEIVED AND AN INVESTIGATION WAS PERFORMED. THIS IS THE 4TH RELATED COMPLAINT FOR NEEDLE CLOG ON THE REPORTED LOT NUMBER. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. BD WAS ABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE AND BASED ON TREND ANALYSIS NO FURTHER ACTION IS REQUIRED AT THIS TIME. SAMPLES RETURNED - CUSTOMER RETURNED (5) OPEN 32GX4MM BD PEN NEEDLES FROM LOT# 0253601. THE CONSUMER REPORTED THAT THE NEEDLES CLOGGED DURING THE INJECTION. ALL 5 RETURNED PEN NEEDLES WERE EXAMINED AND IT WAS OBSERVED THAT 1 EXHIBITED A BENT NON-PATIENT END (NPE) CANNULA, 1 A BROKEN NPE CANNULA, AND 3 A STRAIGHT NPE CANNULA. THE 3 SAMPLES WITH STRAIGHT NPE CANNULAS WERE TESTED FOR FLOW USING A TEST PEN INJECTOR: ALL 3 WERE ABLE TO EXPEL PROPERLY. NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED ON THE RETURNED SAMPLES. THE BENT AND BROKEN NPE CANNULAS WOULD BE THE CAUSE FOR NO FLOW THROUGH THE PEN NEEDLES, HENCE, THE USER WOULD THINK THAT THE PEN NEEDLES WERE CLOGGED. SINCE ALL 5 SAMPLES WERE RETURNED AFTER USE THE PROBABLE CAUSE OF THE BENT AND BROKEN NPE CANNULAS IS USER RELATED. CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMERS INDICATED FAILURE (NPE CANNULA BENT, NPE CANNULA BROKEN). CAPA/SA - BASED ON THE ABOVE INVESTIGATION NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) ARE REQUIRED AT THIS TIME. DHR REVIEW - 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 6 BD PEN NDL 32G 4MM PRO WERE UNABLE TO DELIVER INSULIN OR MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿ THE CONSUMER REPORTED NEEDLES CLOG DURING INJECTION AS IT TOOK 6 PEN NEEDLES TO COMPLETE 1 INJECTION. DATE OF EVENT: (B)(6) 2021. SAMPLE STATUS: AWAITING SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1319956 PEN NDL 32G 4MM PRO HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320550 0253601 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1