BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAG

    MDR report key: 9997907 · Received April 24, 2020

    Report

    Report Number
    1920898-2020-00419
    Event Type
    Malfunction
    Date Received
    April 24, 2020
    Date of Event
    April 3, 2020
    Report Date
    May 8, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249107
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED AS OF 7 MAY 2020 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 # 9210500 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200840071] NOTED FOR OUT OF SPEC SHIELD PULL. INVESTIGATION CONCLUSION: 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 · 0

    IT WAS REPORTED THAT SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAG HAD THE SHIELD NOT DETACH AS INTENDED AND HAD THE HUB SEPARATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT CONSUMER IS HAVING PROBLEMS REMOVING NEEDLE SHIELD FROM SYRINGE AND WHEN IT IS REMOVED THE NEEDLE HUB SEPARATES FROM SYRINGE INTO SHIELD. CONSUMER ATTEMPTED TO REMOVE HUB AND NEEDLE FROM SHIELD WHICH CAUSED THE NEEDLES TO BEND AND CAUSED A NEEDLE STICK. "

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAG HAD THE SHIELD NOT DETACH AS INTENDED AND HAD THE HUB SEPARATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT CONSUMER IS HAVING PROBLEMS REMOVING NEEDLE SHIELD FROM SYRINGE AND WHEN IT IS REMOVED THE NEEDLE HUB SEPARATES FROM SYRINGE INTO SHIELD. CONSUMER ATTEMPTED TO REMOVE HUB AND NEEDLE FROM SHIELD WHICH CAUSED THE NEEDLES TO BEND AND CAUSED A NEEDLE STICK. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462278 SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAG PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 324910 9210500 00382903249107

    Patients

    Seq Age Sex Outcome Treatment
    1 Other