BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG

    MDR report key: 8896587 · Received August 15, 2019

    Report

    Report Number
    1920898-2019-00813
    Event Type
    Injury
    Date Received
    August 15, 2019
    Date of Event
    July 29, 2019
    Report Date
    August 28, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249091
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED WITH ADDITIONAL INFORMATION, DUE TO SAMPLES RECEIVED: DEVICE AVAILABLE FOR EVAL? YES RETURNED TO MANUFACTURER ON: 2019-08-22. 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 CANNULA THROUGH SHIELD AND NEEDLE STICK (AFTER USE) ON LOT # 8337695. INVESTIGATION SUMMARY: SAMPLES FOR BOTH PR-1092234 AND PR-1092275 WERE RETURNED. CUSTOMER RETURNED ONE (1) LOOSE 31G X 6MM, 0.3ML BD INSULIN SYRINGE. CONSUMER REPORTED SYRINGE WENT SIDEWAYS THRU SHIELD STUCK FINGER RECAPPING. THE RETURNED SAMPLE WAS EXAMINED, AND IT WAS OBSERVED THAT THE NEEDLE-HUB/SHIELD ASSEMBLY WAS SEPARATED FROM THE SYRINGE BARREL; NO DAMAGE TO THE BARREL TIP WAS OBSERVED. ISSUES REGARDING NEEDLE-HUB SEPARATION WERE CAPTURED IN PR-1092275. AS NO ISSUES REGARDING CANNULA THROUGH SHIELD OR NEEDLE STICK WERE OBSERVED, THE ALLEGED ISSUES COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8337695. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200802305] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: - UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURES 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 ISSUES ARE UNCONFIRMED. 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 AFTER INJECTION, WHILE RECAPPING THE NEEDLE WENT THROUGH THE SHIELD RESULTING IN NEEDLE STICK INJURY WITH A BD SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (1 OF 2) IT WAS REPORTED BY THE CONSUMER THAT AFTER INJECTING HIS CAT, HE WAS RECAPPING THE NEEDLE, THE NEEDLE WENT THROUGH THE SHIELD RESULTING IN A NEEDLE STICK TO THE CONSUMER. NO MEDICAL ATTENTION RECEIVED FROM THIS INCIDENT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 CANNULA THROUGH SHIELD AND NEEDLE STICK (AFTER USE) ON LOT # 8337695. 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# 8337695. 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. 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 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 AFTER INJECTION, WHILE RECAPPING THE NEEDLE WENT THROUGH THE SHIELD RESULTING IN NEEDLE STICK INJURY WITH A BD SYRINGE 0.3ML 31GA 6MM WHOLE UNIT 10BAG. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (1 OF 2) IT WAS REPORTED BY THE CONSUMER THAT AFTER INJECTING HIS CAT, HE WAS RECAPPING THE NEEDLE, THE NEEDLE WENT THROUGH THE SHIELD RESULTING IN A NEEDLE STICK TO THE CONSUMER. NO MEDICAL ATTENTION RECEIVED FROM THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691906 BD SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 8337695 00382903249091

    Patients

    Seq Age Sex Outcome Treatment
    1 Other