BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5ML 31GA 8MM

    MDR report key: 12239530 · Received July 28, 2021

    Report

    Report Number
    1920898-2021-00825
    Event Type
    Malfunction
    Date Received
    July 28, 2021
    Date of Event
    June 30, 2021
    Report Date
    July 6, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00311917025360
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. 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, THIS IS THE 1ST RELATED COMPLAINT FOR SCALE MARKING DEFECTIVE ON LOT # 7233886 AND 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 CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 1 SYRINGE 0.5ML 31GA 8MM HAD SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED SYRINGES WITH SMEARED SCALE MARKING. DATE OF EVENT : UNKNOWN SAMPLES STATUS : DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1136613 SYRINGE 0.5ML 31GA 8MM PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 928857 7233886 00311917025360

    Patients

    Seq Age Sex Outcome Treatment
    1