BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE INSULIN SYRINGE

    MDR report key: 7695836 · Received July 17, 2018

    Report

    Report Number
    1920898-2018-00509
    Event Type
    Malfunction
    Date Received
    July 17, 2018
    Date of Event
    June 25, 2018
    Report Date
    August 14, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903294169
    PMA / PMN Number
    K170386
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: DUE TO AN IT ISSUE BEGINNING ON 7/3/2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: OTHER. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURER: YES.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) 1CC, 8MM, 31G SYRINGE IN AN OPEN POLY BAG FROM LOT # 7241532. CUSTOMER STATES THAT THE NEEDLE BROKE OFF IN THE VIAL AND THERE IS A HOLE IN THE HUB AND BARREL. THE RETURNED SYRINGE WAS EXAMINED UNDER THE MICROSCOPE AND EXHIBITED A DETACHED CANNULA. THE BARREL EXHIBITED ADHESIVE RUNOFF ONTO THE HE BARREL TIP AND LITTLE ADHESIVE WAS OBSERVED INSIDE THE HUB. NO HOLES IN THE BARREL OR HUB WERE OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7241532. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [200712856, 200712892] NOTED FOR INSUFFICIENT ADHESIVE. THERE WERE FIVE (5) NOTIFICATIONS [200712495, 200712933, 200712764, 200712494, 200712877] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: -CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (ADHESIVE RUNOFF ONTO BARREL) -UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (HOLES IN BARREL AND HUB) INVESTIGATION CONCLUSION: 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. CAPA 226773 HAS BEEN OPENED TO ADDRESS THIS ISSUE FOR 1ML SYRINGES.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD ULTRA-FINE INSULIN SYRINGE THERE WAS AN ISSUE WITH NEEDLE BREAKING AND HOLE IN SYRINGE. THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD ULTRA-FINE INSULIN SYRINGE THERE WAS AN ISSUE WITH NEEDLE BREAKING AND HOLE IN SYRINGE. THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: N/A. 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 NEEDLE BREAKING AND HOLE IN SYRINGE. THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538110 BD ULTRA-FINE INSULIN SYRINGE INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 7241532 00382903294169

    Patients

    Seq Age Sex Outcome Treatment
    1 Other