BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1ML 31G 8MM

    MDR report key: 12247153 · Received July 29, 2021

    Report

    Report Number
    1920898-2021-00832
    Event Type
    Malfunction
    Date Received
    July 29, 2021
    Date of Event
    June 30, 2021
    Report Date
    August 6, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K170386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    G5: IS COMBINATION PRODUCT? NO. THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-08-03. H6: INVESTIGATION SUMMARY CUSTOMER RETURNED (1) LOOSE 1ML U-40 BD INSULIN SYRINGE. THE CUSTOMER REPORTED THAT THE NEEDLE WAS ABOUT TO BE BROKEN. THE RETURNED SYRINGE WAS EXAMINED, AND IT WAS OBSERVED THAT THE CANNULA WAS BENT. NO FURTHER DAMAGE WAS OBSERVED ON THE SYRINGE. NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED. SINCE THE SAMPLE WAS RETURNED AFTER USE THE PROBABLE CAUSE OF THE BENT CANNULA CAN BE TRACED TO THE USER. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0202215. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (CANNULA BENT). 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. THE ROOT CAUSE FOR THIS ISSUE IS USER RELATED. THE CANNULA WAS BENT AFTER THE USER HANDLED THE SYRINGE. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 SYRINGE 1ML 31G 8MM CANNULA BROKE OFF . THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED THAT WHILE TAKING INSULIN INJECTIONS THE NEEDLE BROKE OFF.

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION IS PENDING 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 1 SYRINGE 1ML 31G 8MM CANNULA BROKE OFF . THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED THAT WHILE TAKING INSULIN INJECTIONS THE NEEDLE BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1146377 SYRINGE 1ML 31G 8MM PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 0202215

    Patients

    Seq Age Sex Outcome Treatment
    1