BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE INSULIN SYRINGE

    MDR report key: 8258560 · Received January 17, 2019

    Report

    Report Number
    1920898-2019-00030
    Event Type
    Malfunction
    Date Received
    January 17, 2019
    Date of Event
    January 9, 2019
    Report Date
    January 31, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249183
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED PHOTOS OF A SYRINGE AND POLY BAG FOR 1CC, 6MM, 31G SYRINGES. CUSTOMER STATES THAT WHEN HE REMOVED THE SHIELD, HE MENTIONS THAT THE NEEDLE HAS 2CM, 3 TIMES LARGER THAN IT SAYS IN THE PACKAGE, THIS IS IT SHOULD HAVE 6MM. ALSO, SINCE THE SAMPLE IS OUT OF THE POLY BAG, THIS ISSUE CANNOT BE CONFIRMED AS A MANUFACTURING DEFECT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 5243890. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [200611400, 200611399] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS THE SAMPLE IS OUT OF THE POLY BAG. 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. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE BD ULTRA-FINE¿ INSULIN SYRINGE THE NEEDLE SIZE WAS DIFFERENT THAN THE DESCRIPTION ON THE BOX.

    Additional Manufacturer Narrative · 1

    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 BEFORE USE OF THE BD ULTRA-FINE¿ INSULIN SYRINGE THE NEEDLE SIZE WAS DIFFERENT THAN THE DESCRIPTION ON THE BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52400 BD ULTRA-FINE INSULIN SYRINGE BD ULTRA-FINE¿ INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 5243890 00382903249183

    Patients

    Seq Age Sex Outcome Treatment
    1 Other