BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ INSULIN SYRINGE

    MDR report key: 8178897 · Received December 19, 2018

    Report

    Report Number
    1920898-2018-00961
    Event Type
    Malfunction
    Date Received
    December 19, 2018
    Date of Event
    December 4, 2018
    Report Date
    January 24, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K941657
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) LOOSE 1/2CC, 12.7MM SYRINGE. CUSTOMER STATES THAT A PART OF THE SCALE WASN'T PRINTED. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED MISSING SCALE MARKINGS AS WELL AS INK SMEARS ON THE BARREL. CAPA 162566 WAS IMITATED TO ADDRESS PRINTING ISSUES. UNABLE TO PERFORM DHR CHECK DUE TO UNKNOWN LOT NUMBER. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. 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. POSSIBLE ROOT CAUSE IS ATTRIBUTED TO PAD SWELLING ON THE MANDRIL DURING THE PRINTING PROCESS. AS THE PADS ARE USED, THEY GRADUALLY SWELL AND CAN CAUSE THIS TYPE OF "SMEAR" OR "SMUDGE AFFECT. A PROBLEM SOLVING TEAM HAS BEEN TASKED WITH IMPROVING PRINT QUALITY ON ALL PRODUCTION LINES WITHIN THE PLANT. THE TEAM IS SYSTEMATICALLY ASSESSING AND ADDRESSING EACH PRINTER INDIVIDUALLY FOR IMPROVEMENTS. CAPA 162566 WAS IMITATED TO ADDRESS PRINTING ISSUES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE BD ULTRA-FINE¿ INSULIN SYRINGE THE SCALE WASN'T PRINTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE OF THE BD ULTRA-FINE¿ INSULIN SYRINGE THE SCALE WASN'T PRINTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1017348 BD ULTRA-FINE¿ INSULIN SYRINGE INSULIN SYRINGE WITH NEEDLE FMF BD MEDICAL - DIABETES CARE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other