BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE

    MDR report key: 8465935 · Received March 29, 2019

    Report

    Report Number
    1920898-2019-00295
    Event Type
    Malfunction
    Date Received
    March 29, 2019
    Date of Event
    March 8, 2019
    Report Date
    April 4, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K170386
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: CUSTOMER RETURNED (115) 1CC, 12.7MM, 30G SYRINGES (5 LOOSE, 110 IN SEALED POLY BAGS) WITH THE SHELF CARTONS FROM LOT # 7241942. CUSTOMER STATES THAT THERE WAS A SUBSTANCE BLOCKING THE CAVITY INSIDE THE SYRINGE. ALL LOOSE SAMPLES AS WELL AS THIRTY SAMPLES FROM THE SEALED POLY BAGS WERE EXAMINED AND 3 LOOSE SAMPLES AS WELL AS 7 OUT OF 30 SAMPLES FROM THE SEALED POLY BAGS EXHIBITED ADHESIVE RUNOFF ONTO THE BARREL. CAPA 226773 HAS BEEN OPENED TO ADDRESS THIS ISSUE FOR 1ML SYRINGES. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7241942. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE SIX (6) NOTIFICATIONS [200712761, 200712700, 200712546, 200712545, 200712544, 200712186] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (ADHESIVE RUNOFF). PROBABLE ROOT CAUSE DETERMINED TO BE MISALIGNMENT DURING APPLICATION OF ADHESIVE ON THE NEEDLE LINES. WHEN THIS OCCURS, ADHESIVE RUNOVER ONTO THE HUB OR POSSIBLE THE CANNULA MAY OCCUR. ADDITIONALLY, ADHESIVE MAY BE INACCURATELY APPLIED TO THE RUBBERIZED PULL WHEEL ON THE LINE, WHICH CAN ADDITIONALLY TRANSFER ADHESIVE TO THE CANNULA DURING ROUTINE USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE THERE WAS A SUBSTANCE BLOCKING THE CAVITY INSIDE THE SYRINGE. VERBTIM: BASICALLY, THERE ARE 3 CAVITIES INSIDE THE SYRINGE NEAR TO THE NEEDLE HOUSING. USUALLY THESE 3 CAVITIES ARE HOLLOW AND NOTHING INSIDE. THIS PARTICULAR SYRINGE HAD 2 CAVITIES AND 1 CAVITY FILLED WITH SOME MATERIAL.

    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. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE OF THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE THERE WAS A SUBSTANCE BLOCKING THE CAVITY INSIDE THE SYRINGE. VERBTIM: BASICALLY, THERE ARE 3 CAVITIES INSIDE THE SYRINGE NEAR TO THE NEEDLE HOUSING. USUALLY THESE 3 CAVITIES ARE HOLLOW AND NOTHING INSIDE. THIS PARTICULAR SYRINGE HAD 2 CAVITIES AND 1 CAVITY FILLED WITH SOME MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256321 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 7241942

    Patients

    Seq Age Sex Outcome Treatment
    1 Other