BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 0.3ML 31GA 8MM 10BAG

    MDR report key: 9534197 · Received December 31, 2019

    Report

    Report Number
    1920898-2019-01488
    Event Type
    Malfunction
    Date Received
    December 31, 2019
    Date of Event
    December 9, 2019
    Report Date
    December 11, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00311917048154
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. 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 SCALE MARKING ILLEGIBLE AND NEEDLE BENDING DURING USE ON LOT # 8232713. 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# 8232713. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. 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 HAS BEEN REPORTED THAT THE BD¿ SYRINGE 0.3ML 31GA 8MM 10BAG HAS BEEN FOUND EXPERIENCING SCALE MARKING ISSUES DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE CUSTOMER IS HAVING HARD TIME READING SCALE WITH 1/2 UNIT SCALE. DRAWING 2 UNITS FOR PET AND THE NEEDLES ARE BENDING WHEN INSERTING INTO THE SITE. VERBATIM: ISSUE(S): HARD TIME READING SCALE WITH 1/2 UNIT SCALE. DRAWING 2 UNITS FOR PET ISSUE(S): NEEDLES ARE BENDING WHEN INSERTING INTO THE SITE. LOT #: 8232713, ITEM #: 928858, DATE OF EVENT: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1331624 BD SYRINGE 0.3ML 31GA 8MM 10BAG PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 8232713 00311917048154

    Patients

    Seq Age Sex Outcome Treatment
    1 Other