BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ INSULIN SYRINGE

    MDR report key: 7152655 · Received December 28, 2017

    Report

    Report Number
    9614033-2017-00014
    Event Type
    Malfunction
    Date Received
    December 28, 2017
    Date of Event
    December 4, 2017
    Report Date
    April 20, 2018
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: INVESTIGATION SUMMARY: CUSTOMER RETURNED PHOTOS OF A 1CC, 13MM, 30G SYRINGE AND THE SHELF CARTON FROM LOT # 6277567. CUSTOMER STATES THAT TWO OF THE SYRINGES HAVE A CLEAR LIQUID AT THE TIP. THE RETURNED PHOTOS WERE EXAMINED AND EXHIBITED A CLEAR DROPLET OF MATERIAL ON THE CANNULA SHAFT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 6277567. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE FIVE (5) NOTIFICATIONS [(B)(4)] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. SEVERITY: S1; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED FOR THE DEFECT/CONDITION ON LOT NUMBER 6277567. POSSIBLE ROOT CAUSE FOR THIS ISSUE CANNOT BE DETERMINED AS THE IDENTITY OF THE CLEAR DROPLET OF MATERIAL ON THE CANNULA SHAFT CANNOT BE DETERMINED WITHOUT THE SAMPLE TO ANALYZE. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER WAS SEEN ON THE TIP OF A BD ULTRA-FINE¿ INSULIN SYRINGE BEFORE USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    930075 BD ULTRA-FINE¿ INSULIN SYRINGE INSULIN SYRINGE FMF BECTON DICKINSON DE MEXICO 6277567

    Patients

    Seq Age Sex Outcome Treatment
    1 Other