BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ INSULIN SYRINGE

    MDR report key: 8151517 · Received December 11, 2018

    Report

    Report Number
    9614033-2018-00095
    Event Type
    Malfunction
    Date Received
    December 11, 2018
    Date of Event
    November 20, 2018
    Report Date
    February 4, 2019
    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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED PHOTOS OF 3/10CC SYRINGES. CUSTOMER STATES THAT THE NEEDLES OF THE SYRINGE HAVE A PROTRUSION. THE PHOTOS WERE EXAMINED AND EXHIBITED CLEAR MATERIAL ON THE CANNULA SHAFT. IT IS DIFFICULT TO DETERMINE THE IDENTITY OF THIS MATERIAL SOLELY FROM THE PHOTOS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 7240696 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE THREE (3) NOTIFICATIONS [200727627, 200727438, 200727290] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: -CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE, HOWEVER, IT IS DIFFICULT TO DETERMINE THE IDENTITY OF THIS MATERIAL SOLELY FROM THE PHOTOS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE BD ULTRA-FINE¿ INSULIN SYRINGE HAD ISSUE WITH FOREIGN MATTER.

    Additional Manufacturer Narrative · 1

    (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 HAD ISSUE WITH FOREIGN MATTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    989745 BD ULTRA-FINE¿ INSULIN SYRINGE INSULIN SYRINGE FMF BECTON DICKINSON DE MEXICO 7240696

    Patients

    Seq Age Sex Outcome Treatment
    1 Other