BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE

    MDR report key: 7495970 · Received May 8, 2018

    Report

    Report Number
    1920898-2018-00325
    Event Type
    Malfunction
    Date Received
    May 8, 2018
    Date of Event
    April 26, 2018
    Report Date
    August 8, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908468039
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH#: 6102709. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE FOUR (4) NOTIFICATIONS [200645935, 200641668, 200641369, 200641638] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. SEVERITY: S_2__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR NEEDLE HUB SEPARATED DURING INJECTION AND THE 1ST RELATED COMPLAINT FOR NEEDLE CLOG ON LOT#: 6102709. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE THERE WAS AN ISSUE WITH NEEDLE/HUB SEPARATION. IT WAS STATED ¿THE NEEDLE WAS CLOGGED AND THE HUB SEPARATED FROM THE SYRINGE DURING INJECTION. DURING THE INJECTION AND WHILE PRESSING DOWN THE PLUNGER, THE NEEDLE HUB ASSEMBLY POPPED OUT OF THE BARREL. WHEN CONSUMER TRIED TO PRESS ON PLUNGER INSULIN WOULD NOT GO THRU.¿ THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. 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 INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE THERE WAS AN ISSUE WITH NEEDLE/HUB SEPARATION. IT WAS STATED ¿THE NEEDLE WAS CLOGGED AND THE HUB SEPARATED FROM THE SYRINGE DURING INJECTION. DURING THE INJECTION AND WHILE PRESSING DOWN THE PLUNGER, THE NEEDLE HUB ASSEMBLY POPPED OUT OF THE BARREL. WHEN CONSUMER TRIED TO PRESS ON PLUNGER INSULIN WOULD NOT GO THRU.¿ THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336291 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 6102709 00382908468039

    Patients

    Seq Age Sex Outcome Treatment
    1 Other