BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE SHORT PEN NEEDLE

    MDR report key: 15089827 · Received July 22, 2022

    Report

    Report Number
    9616656-2022-00768
    Event Type
    Malfunction
    Date Received
    July 22, 2022
    Date of Event
    June 22, 2022
    Report Date
    July 13, 2022
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY : EXEC SUMMARY - NO PHYSICAL DEVICE SAMPLES WERE RETURNED. 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 (DIFFICULT OR UNABLE TO OPERATE) ON THIS LOT # 0014201. 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 OR PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) ARE REQUIRED AT THIS TIME. DHR REVIEW - A LOT HISTORY REVIEW FOR THIS BATCH # 0014201 WAS 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 · 0

    IT WAS REPORTED THAT THE BD ULTRA-FINE SHORT PEN NEEDLE EXPERIENCED DIFFICULT DEVICE OPERATION, AND PRODUCT DAMAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM PORTUGUESE TO ENGLISH : THE PATIENT REPORTED THAT AN INSULIN PEN WHEN CHOOSING THE UNIT TO INJECT THE MEDICATION, THE DOSAGE BUTTON LOCKED AND A PIECE OF THE PEN ITSELF FELL OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608136 BD ULTRA-FINE SHORT PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 0014201

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Male