BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE INSULIN SYRINGE

    MDR report key: 10247918 · Received July 8, 2020

    Report

    Report Number
    1920898-2020-00804
    Event Type
    Malfunction
    Date Received
    July 8, 2020
    Date of Event
    June 18, 2020
    Report Date
    July 15, 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 SUMMARY: A SAMPLES WERE RETURNED, BUT ONLY A PHOTO INVESTIGATION WAS PERFORMED. TWO PHOTOS OF A 0.3ML BD INSULIN SYRINGE WERE PROVIDED. CONSUMER REPORTED WHEN REMOVING THE SHIELD BEFORE USE, THE NEEDLE WITH THE SHIELD WAS SEPARATED FROM THE HUB. THE PROVIDED PHOTOS WERE EXAMINED, AND IT WAS OBSERVED THAT THE NEEDLE HUB/SHIELD ASSEMBLY WAS SEPARATED FROM THE SYRINGE BARREL; NO DAMAGE TO THE BARREL TIP WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9231316. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200842714] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE BASED ON THE PHOTOS RECEIVED. ROOT CAUSE FOR THIS DEFECT CANNOT BE DETERMINED. CAPA 1630423 HAS BEEN OPENED TO ADDRESS THIS ISSUE. H3 OTHER TEXT : 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 BEFORE USE, THE NEEDLE WITH THE SHIELD 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 BEFORE USE, THE NEEDLE WITH THE SHIELD WAS SEPARATED FROM THE HUB."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712742 BD ULTRA-FINE INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 9231316

    Patients

    Seq Age Sex Outcome Treatment
    1 Other