BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ THIN WALL 31G X 5MM VALUE BRAND

    MDR report key: 14258318 · Received May 2, 2022

    Report

    Report Number
    9616656-2022-00491
    Event Type
    Malfunction
    Date Received
    May 2, 2022
    Date of Event
    April 6, 2022
    Report Date
    April 13, 2022
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 # 1202194. 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 BATCH # 1202194 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 3 BD¿ THIN WALL 31G X 5MM VALUE BRAND NEEDLES WERE DIFFICULT TO OPERATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CUSTOMER RETURNED 3 STANDARD BD PEN NEEDLES REPORTING TOO MUCH INSULIN FLOWED THROUGH THEM DURING EXPRESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1568694 BD¿ THIN WALL 31G X 5MM VALUE BRAND HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 1202194

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown