BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ INSULIN SYRINGE

    MDR report key: 8186832 · Received December 20, 2018

    Report

    Report Number
    9614033-2018-00098
    Event Type
    Malfunction
    Date Received
    December 20, 2018
    Date of Event
    November 28, 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

    CORRECTION: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED WITH THE USE OF THE BD ULTRA-FINE¿ INSULIN SYRINGE THERE WAS AN ISSUE WITH FOREIGN MATTER AT THE TIP OF THE NEEDLE. THIS WAS REPORTED TO HAVE AFFECTED 4 SYRINGES. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 8043557 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE FOUR (4) NOTIFICATIONS [200749616, 200749580, 200749159, 200750392] 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 NO SAMPLES OR PHOTOS WERE RETURNED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD ULTRA-FINE¿ INSULIN SYRINGE THERE WAS AN ISSUE WITH FOREIGN MATTER AT THE TIP OF THE NEEDLE. THIS WAS REPORTED TO HAVE AFFECTED 4 SYRINGES.

    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 WITH THE USE OF THE BD ULTRA-FINE¿ INSULIN SYRINGE THERE WAS AN ISSUE WITH FOREIGN MATTER AT THE TIP OF THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1023696 BD ULTRA-FINE¿ INSULIN SYRINGE INSULIN SYRINGE FMF BECTON DICKINSON DE MEXICO 8043557

    Patients

    Seq Age Sex Outcome Treatment
    1 Other