BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 0.3ML 31GA 8MM 10BAG

    MDR report key: 9451923 · Received December 11, 2019

    Report

    Report Number
    1920898-2019-01412
    Event Type
    Malfunction
    Date Received
    December 11, 2019
    Date of Event
    November 26, 2019
    Report Date
    November 27, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131311786
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9133811, MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: 2019-07-11. MEDICAL DEVICE LOT #: UNKNOWN, MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: UNKNOWN. 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 CANNULA SEPARATES ON LOT # 9133811. UNABLE TO PERFORM COMPLAINT LOT HISTORY CHECK FOR CANNULA SEPARATES DUE TO UNKNOWN LOT NUMBER. 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 #9133811. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS EXCEPT AS NOTED BELOW. THERE WAS ONE (1) NOTIFICATION NOTED FOR CRACKED HUBS. 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 FIVE OCCURRENCES OF THE NEEDLE PULLING OUT DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT EVERY OTHER PACK, CONSUMER NOTICED NEEDLE DETACHED FROM THE BARREL. VERBATIM: MATERIAL NO: 328512, BATCH NO: 9133811, UNKNOWN. IT WAS REPORTED THAT EVERY OTHER PACK, CONSUMER NOTICED NEEDLE DETACHED FROM THE BARREL. VERBATIM: ISSUE: EVERY OTHER PACK, CONSUMER NOTICED NEEDLE DETACHED FROM THE BARREL. SHE NOTICED TOTAL OF 5, SAMPLE DISCARDED. SHE USES THE 31G, 3/10ML, 8MM. INCIDENT DATE-UNKNOWN OCCURRED -5, ITEM#-328512, LOT# 9133811. IN THE PAST:NEEDLE IS DETACHED FROM THE BARREL HAS OCCURRED IN THE PAST. SAMPLE DISCARDED. INCIDENT DATE-UNKNOWN, OCCURRENCE-UNKNOWN, ITEM# 328512, LOT# UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1250066 BD SYRINGE 0.3ML 31GA 8MM 10BAG PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE SEE H.10 00681131311786

    Patients

    Seq Age Sex Outcome Treatment
    1 Other