BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETY-LOK¿ INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE

    MDR report key: 7213938 · Received January 23, 2018

    Report

    Report Number
    1920898-2018-00035
    Event Type
    Malfunction
    Date Received
    January 23, 2018
    Date of Event
    December 14, 2017
    Report Date
    January 29, 2018
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FMI
    PMA / PMN Number
    K944757
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: CUSTOMER RETURNED (1) BD 1CC, 13MM, 29G SAFETYLOK SYRINGE IN A SEALED BLISTER PACK FROM LOT # 7040501. CUSTOMER STATES THAT THERE WAS SILICONE OIL ON SYRINGES CAUSING CLOUDINESS/PARTICULATE MATTER IN NOVOLOG VIALS. THE RETURNED SYRINGE WAS EXAMINED VISUALLY AND UNDER THE MICROSCOPE AND NO LIQUID WAS OBSERVED INSIDE THE SYRINGE AND NO LIQUID CAME OUT OF THE SYRINGE WHEN FULLY DEPRESSING THE PLUNGER ROD. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7040501. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE THREE (3) NOTIFICATIONS THAT DID NOT PERTAIN TO THE COMPLAINT. CONCLUSION: BASED ON THE SAMPLE RECEIVED BD WAS NOT 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. BASED ON THE ABOVE, 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. MEDICAL DEVICE EXPIRATION DATE: N/A. 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 WITH BD ULTRA-FINE¿ NEEDLE SYRINGE HAD SILICON OIL ON THE SYRINGES CAUSING CLOUDINESS/PARTICULATE MATTER IN THE NOVOLOG VIALS. FOUND BEFORE USE. NO SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57994 BD SAFETY-LOK¿ INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 7040501

    Patients

    Seq Age Sex Outcome Treatment
    1 Other