BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE

    MDR report key: 9324591 · Received November 14, 2019

    Report

    Report Number
    1920898-2019-01294
    Event Type
    Malfunction
    Date Received
    November 14, 2019
    Date of Event
    October 30, 2019
    Report Date
    November 6, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908411035
    PMA / PMN Number
    K170386
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. 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. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8190578. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [(B)(4)] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. INVESTIGATION CONCLUSION: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEEDLE LENGTH ERROR OCCURRED DURING USE WITH A BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "ISSUE: SPOUSE REPORTED HER HUSBAND THINKS THESE NEEDLES ARE LONGER, INCIDENT DATE-UNKNOWN, SPOUSE DOES NOT KNOW HOW MANY OF THE NEEDLES USED WERE LONGER. SAMPLE DISCARDED. ITEM: 328411, LOT# 8190578, EXPIRATION DATE-2023-07-31. ISSUE: BENT -SPOUSE REPORTED NEEDLE BENT DURING INJECTION ON SKIN, SAMPLE DISCARDED. INCIDENT DATE-UNKNOWN, SPOUSE IS NOT SURE HOW MANY TIMES IT HAS OCCURRED. ITEM: 328411, LOT# 8190578, EXPIRATION DATE-2023-07-31. SPOKE TO THE CONSUMER VERIFIED THE SYRINGES CAPACITY 1ML, 12.7MM G30G. HE DOES NOT THINK THE DOCTOR HAS CHANGED THE PRESCRIPTION OF THE SYRINGES, BUT HE THINKS THIS IS LONGER. HE HAS BEEN GETTING IT FROM THE PHARMACY. HE IS 90 YEARS OLD, HE HAS BEEN A DIABETIC FOR LONG. CONSUMER USES NEW SYRINGES EACH TIME OF HIS INJECTION, HE AND SPOUSE REMOVES IT STRAIGHT OUT OF THE NEEDLE SHIELD. ADVISED TO SAVE THE SAMPLE IF RE OCCURRENCE. OFFERED TO SEND THE REPLACEMENT." 1 OF 3 COMPLAINTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1114470 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 8190578 00382908411035

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Other