BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ 3/10ML INSULIN SYRINGE

    MDR report key: 15085217 · Received July 22, 2022

    Report

    Report Number
    1920898-2022-00472
    Event Type
    Malfunction
    Date Received
    July 22, 2022
    Date of Event
    June 22, 2022
    Report Date
    July 28, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED (5) 3/10CC, 12.7MM, 29G SYRINGES IN AN OPEN POLY BAG FROM LOT # 1200370. CUSTOMER STATES THAT WHEN THE PLUNGER ROD WAS PUSHED, A LIQUID CAME OUT IN FIVE OF SEVEN PRODUCTS. ALL RETURNED SYRINGES WERE TESTED AND A CLEAR DROP OF MATERIAL CAME OUT OF THE CANNULA OF 4 OUT OF 5 SAMPLES. A SMALL PORTION OF THIS MATERIAL WAS REMOVED FROM THE SAMPLE AND PREPARED FOR FTIR SPECTRAL ANALYSIS. THE SPECTRAL ANALYSIS SHOWS THAT THIS MATERIAL IS MOST LIKELY SILICONE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 1200370 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE THREE (3) NOTIFICATIONS NOTED FOR POOLING. EMBECTA WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. ROOT-CAUSE: BASED ON (B)(4), OPERATOR FOUND EXCESS LUBE INSIDE THE BARRELS DURING IN-PROCESS INSPECTION, THE DEFECT OCCURRED DUE TO DAMAGED ADHESIVE NOZZLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FIVE OF THE SEVEN BD ULTRA-FINE¿ 3/10ML INSULIN SYRINGES HAD A FOREIGN MATTER COME OUT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN THE HCP PUSHED THE PLUNGER ROD, A LIQUID CAME OUT IN FIVE OF SEVEN PRODUCTS.¿

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FIVE OF THE SEVEN BD ULTRA-FINE¿ 3/10ML INSULIN SYRINGES HAD A FOREIGN MATTER COME OUT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN THE HCP PUSHED THE PLUNGER ROD, A LIQUID CAME OUT IN FIVE OF SEVEN PRODUCTS.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566137 BD ULTRA-FINE¿ 3/10ML INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 1200370

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown