BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEN NDL 31GA 8MM

    MDR report key: 12492759 · Received September 17, 2021

    Report

    Report Number
    9616656-2021-01170
    Event Type
    Malfunction
    Date Received
    September 17, 2021
    Date of Event
    August 20, 2021
    Report Date
    September 6, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903201099
    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

    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 # : 5190053 ¿ DEVICE EXPIRATION DATE : UNKNOWN. DEVICE MANUFACTURE DATE : 07/27/2015. LOT # : 6145820 ¿ DEVICE EXPIRATION DATE : UNKNOWN. DEVICE MANUFACTURE DATE : 05/24/2016. THE CUSTOMER'S ADDRESS IS UNKNOWN. (B)(6) USA HAS BEEN USED AS A DEFAULT. 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 COMPLAINT LOT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR INCORRECT/MISSING LABEL INFORMATION ON THESE LOT #S. NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THESE LOTS 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 FOR BATCHES 5190053 AND 6145820 WERE CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THESE PACKAGED LOTS CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 BD PEN NDL 31GA 8MM HAD A LABEL INFORMATION ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CONSUMER CALLED TO INQUIRY ABOUT EXPIRATION DATE ON PEN NEEDLES AND STATED THAT THERE IS NO DATE ON THE BOX. DATE OF EVENT: UNKNOWN. SAMPLES: NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1387357 BD PEN NDL 31GA 8MM HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320109 SEE H.10 00382903201099

    Patients

    Seq Age Sex Outcome Treatment
    1