BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE INSULIN SYRINGE

    MDR report key: 10365265 · Received August 4, 2020

    Report

    Report Number
    1920898-2020-00992
    Event Type
    Malfunction
    Date Received
    August 4, 2020
    Date of Event
    July 15, 2020
    Report Date
    August 12, 2020
    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

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED (8) 1/2CC, 12.7MM, 29G SYRINGES (1 IN AN OPEN POLY BAG, 7 IN A SEALED POLY BAG) FROM LOT # 9231037. CUSTOMER STATES THAT WHEN REMOVING THE SHIELD, THE NEEDLE WITH THE SHIED WAS SEPARATED FROM THE HUB. ALL RETURNED SYRINGES WERE EXAMINED AND THE HUB-NEEDLE ASSEMBLY SEPARATED WITH THE SHIELD WHEN THE SHIELD WAS REMOVED FROM THE BARREL FROM THE SAMPLE IN THE OPEN POLY BAG. NO DEFECTS WERE OBSERVED ON THE SAMPLES IN THE SEALED POLY BAG. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9252463. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200843229] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. PROCESS SUMMARY: AUTOMATIC SYRINGE ASSEMBLY MACHINE, WHICH FEEDS 0.5ML, SYRINGE COMPONENTS (BARREL, STOPPER, PLUNGER, NEEDLE ASSEMBLY & CAP) AND ASSEMBLES THESE COMPONENTS. THIS MACHINE CONSISTS OF A BARREL CLEANING DIAL, LUBRICATION DIAL, PLUNGER/STOPPER ASSEMBLY DIAL, SYRINGE ASSEMBLY DIAL, AND VARIOUS INSPECTIONS AND TRANSFER DIALS. ROOT CAUSE: L2L DISPATCH #77301 WAS CREATED FOR HIGH HUBS. DEBRIS WAS COLLECTED ON THE DIAL. CORRECTIVE ACTION: CLEANED THE DEBRIS OUT OF THE DIAL. SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE HUB SEPARATED FROM THE BD ULTRA-FINE¿ INSULIN SYRINGE BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "WHEN REMOVING THE SHIELD, THE NEEDLE WITH THE SHIED WAS SEPARATED FROM THE HUB."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE HUB SEPARATED FROM THE BD ULTRA-FINE¿ INSULIN SYRINGE BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "WHEN REMOVING THE SHIELD, THE NEEDLE WITH THE SHIED WAS SEPARATED FROM THE HUB."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829642 BD ULTRA-FINE INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 9231037

    Patients

    Seq Age Sex Outcome Treatment
    1 Other