BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETY-LOK¿ INSULIN SYRINGE

    MDR report key: 7203106 · Received January 18, 2018

    Report

    Report Number
    1920898-2017-00447
    Event Type
    Malfunction
    Date Received
    January 18, 2018
    Date of Event
    December 28, 2017
    Report Date
    February 1, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    RESULTS: SEVERITY: S1; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED FOR THE DEFECT/CONDITION ON LOT NUMBER 4140670. BD RECEIVED ONE (1) BD 1CC 13MM, 29G SAFETY-LOK SYRINGE FROM THE CUSTOMER IN AN OPEN BLISTER PACK FROM LOT # 4140670. CUSTOMER STATES THAT THE AMOUNT EQUIVALENT TO 100 IU IN THE SYRINGE IS GREATER THAN 1 ML. THE RETURNED SYRINGE WAS TESTED USING THE PLUG GAUGE AND ALL SCALE MARKINGS FALL WITHIN SPECIFICATIONS. AS PER MANUFACTURING, A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 4140670. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE CONCLUSION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED. BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER PHONE: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD SAFETY-LOK¿ INSULIN SYRINGE HAD A GREATER VOLUMETRIC EQUIVALENCY THAN 1 ML. FOUND BEFORE USE. NO REPORTS OR INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46874 BD SAFETY-LOK¿ INSULIN SYRINGE INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 4140670

    Patients

    Seq Age Sex Outcome Treatment
    1 Other