BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE

    MDR report key: 10611102 · Received September 30, 2020

    Report

    Report Number
    1920898-2020-01336
    Event Type
    Malfunction
    Date Received
    September 30, 2020
    Date of Event
    September 23, 2020
    Report Date
    September 30, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908411035
    PMA / PMN Number
    K170386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4). LEVEL B INVESTIGATION: COMPLAINT EVALUATION / COMPLAINT HISTORY CHECK FOR THE EVENT(S) THAT OCCURRED. SEVERITY: S_1__; OCCURRENCE: UNABLE TO PERFORM COMPLAINT LOT HISTORY CHECK FOR PLUNGER DIFFICULT TO MOVE DUE TO UNKNOWN LOT NUMBER. A REVIEW OF RISK MANAGEMENT 150RMN-0001-16 REVISION 14 INDICATES THAT THE POTENTIAL RISK OF THIS SPECIFIC REPORTED INCIDENT (SYRINGE, PLUNGER DIFFICULT TO MOVE) WAS CAPTURED AND ADDRESSED. INVESTIGATION SUMMARY: NO SAMPLES WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. UNABLE TO PERFORM DHR CHECK FOR PLUNGER DIFFICULT TO MOVE DUE TO UNKNOWN LOT NUMBER. 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 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE PLUNGER ROD WAS DIFFICULT TO MOVE. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:328411 BATCH NO: UNKNOWN ( REPORTED 9162996). IT WAS REPORTED THAT THE PLUNGER ROD IS DIFFICULT TO MOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1068874 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328411 UNKNOWN 00382908411035

    Patients

    Seq Age Sex Outcome Treatment
    1 Other