BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE

    MDR report key: 10305692 · Received July 21, 2020

    Report

    Report Number
    1920898-2020-00906
    Event Type
    Malfunction
    Date Received
    July 21, 2020
    Date of Event
    July 6, 2020
    Report Date
    July 10, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908440035
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: LEVEL A INVESTIGATION - COMPLAINT EVALUATION / COMPLAINT HISTORY CHECK FOR THE EVENT(S) THAT OCCURRED. SEVERITY: S_1__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR NEEDLE HUB SEPARATES ON LOT # 9250297. A REVIEW OF RISK MANAGEMENT 150RMN-0001-16 REVISION 13 INDICATES THAT THE POTENTIAL RISK OF THIS SPECIFIC REPORTED INCIDENT (SYRINGE, NEEDLE HUB SEPARATES) WAS CAPTURED AND ADDRESSED APPROPRIATELY. 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# 9350297. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200869089] NOTED FOR OUT OF SPEC SHIELD PULL, INVESTIGATION CONCLUSION: AS NO SAMPLES AND/OR PHOTO(S) WERE 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 COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE EXPERIENCED HUB SEPARATION FROM THE DEVICE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328440 BATCH NO. 9350297, CONSUMER REPORTED, WHEN HE REMOVED SHIELD, NEEDLE HUB SEPARATED. STATED, THE SHIELD WAS NOT DIFFICULT TO REMOVE 1 SYRINGE AFFECTED. DATE OF EVENT: (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770133 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 328440 9350297 00382908440035

    Patients

    Seq Age Sex Outcome Treatment
    1 Other