BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM PRO

    MDR report key: 12368861 · Received August 25, 2021

    Report

    Report Number
    9616656-2021-01048
    Event Type
    Malfunction
    Date Received
    August 25, 2021
    Date of Event
    July 30, 2021
    Report Date
    August 2, 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
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS : LOT # : 0162451, DEVICE EXPIRATION DATE : 06/30/2025, DEVICE MANUFACTURE DATE : 06/10/2020. LOT # : UNKNOWN, DEVICE EXPIRATION DATE : UNKNOWN, DEVICE MANUFACTURE DATE : UNKNOWN. INITIAL REPORTER PHONE# : UNKNOWN. INITIAL REPORTER ZIP CODE : (B)(6). INVESTIGATION SUMMARY : EXEC SUMMARY - NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND THIS IS THE 2ND RELATED COMPLAINT FOR NEEDLE CLOG ON LOT # 0162451. NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. CAPA/SA - BASED ON THE ABOVE 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 # 0162451.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 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 THAT A FEW FROM 2 BOXES CLOG DURING INJECTION. DATE OF EVENT : UNKNOWN. SAMPLE STATUS : DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1265308 PEN NDL 32G 4MM PRO HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320550 SEE H.10 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1