BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYRINGE 0.5ML 31G TW 6MM BLS 400 SG

    MDR report key: 8946745 · Received August 29, 2019

    Report

    Report Number
    1920898-2019-00890
    Event Type
    Injury
    Date Received
    August 29, 2019
    Date of Event
    August 7, 2019
    Report Date
    August 23, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    MEG
    PMA / PMN Number
    K992734
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: LEVEL B INVESTIGATION. COMPLAINT EVALUATION / COMPLAINT HISTORY CHECK FOR THE EVENT(S) THAT OCCURRED. SEVERITY: S_3__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR DIFFICULT/UNABLE TO OPERATE SAFETY MECHANISM, NEEDLE STICK (AFTER USE) ON LOT # 9063601. 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# 9063601. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200810257] 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 SYRINGE 0.5ML 31G TW 6MM BLS 400 SG HAS BEEN FOUND EXPERIENCING SAFETY SHIELD FAILURE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE CONSUMER MET RESISTANCE WHEN ATTEMPTING TO ACTIVATE THE SAFETY AND THAT SHE NEVER WAS ABLE TO ACTIVATE IT AND DISCARDED IT IN THE SHARPS CONTAINER. SHE DID STICK HERSELF WITH THE NEEDLE WHILE SHE WAS TRYING TO ACTIVATE THE SAFETY. VERBATIM: THE EVENT INVOLVED A BD SAFETY GLIDE 30G INSULIN NEEDLE WITH THE LOT NUMBER 9063601C AND AN EXPIRATION OF 2/29/2024. SHE INDICATES SHE MET RESISTANCE WHEN ATTEMPTING TO ACTIVATE THE SAFETY AND THAT SHE NEVER WAS ABLE TO ACTIVATE IT AND DISCARDED IT IN THE SHARPS CONTAINER. SHE DID STICK HERSELF WITH THE NEEDLE WHILE SHE WAS TRYING TO ACTIVATE THE SAFETY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738210 SYRINGE 0.5ML 31G TW 6MM BLS 400 SG ANTISTICK SYRINGE MEG BD MEDICAL - DIABETES CARE 9063601

    Patients

    Seq Age Sex Outcome Treatment
    1 Other