BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 30GA 8MM 7BAG 420CAS JP

    MDR report key: 10360386 · Received August 3, 2020

    Report

    Report Number
    1920898-2020-00986
    Event Type
    Malfunction
    Date Received
    August 3, 2020
    Date of Event
    June 24, 2020
    Report Date
    July 30, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS RECEIVED ON (B)(6) 2020 AND DETERMINED TO BE NOT REPORTABLE. ON (B)(6) 2020 SAMPLES WERE RECEIVED AND THE SAMPLE SHOWED THAT THE NEEDLE SHIELD WITH HUB WAS DETACHED FROM THE BARREL, A NEW A DECISION TREE WAS COMPLETED AND DETERMINED TO BE MDR REPORTABLE. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(4). INVESTIGATION SUMMARY: CUSTOMER RETURNED PHOTOS OF A 3/10CC, 8MM, 30G SYRINGE WITH A POLY BAG FROM LOT # 9231320. CUSTOMER STATES THAT THE SHIELD WAS TOO TIGHT TO REMOVE. PHOTOS WERE EXAMINED AND EXHIBITED THE HUB-NEEDLE/SHIELD ASSEMBLY SEPARATED FROM THE BARREL. MANUFACTURING ((B)(4)) WILL BE NOTIFIED OF THIS ISSUE. LEVEL A EVENT NO DHR OR QN REVIEW IS REQUIRED. CONCLUSION: BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (HUB SEPARATES). ROOT CAUSE: L2L DISPATCH (B)(4) WAS CREATED FOR RAISED HUBS. THE PRESS STATION WAS OUT OF ADJUSTMENT. CORRECTIVE ACTION: THE PRESS STATION WAS ADJUSTED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. CAPA # (B)(4) HAS BEEN OPENED TO ADDRESS THIS ISSUE OF HUB SEPARATES." RATIONALE: BD HAS INITIATED FURTHER ROOT CAUSE INVESTIGATION RELATING TO THE ISSUE OF HUB SEPARATION THROUGH A CORRECTIVE AND PREVENTIVE ACTION (CAPA (B)(4)).

    Description of Event or Problem · 1

    IT WAS REPORTED BEFORE USE THE SYRINGE 0.3ML 30GA 8MM 7BAG 420CAS JP HAD THE HUB SEPARATE FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER STATED "THE SHIELD WAS TOO TIGHT TO REMOVE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818718 SYRINGE 0.3ML 30GA 8MM 7BAG 420CAS JP SYRINGE WITH NEEDLE FMF BD MEDICAL - DIABETES CARE 9231320

    Patients

    Seq Age Sex Outcome Treatment
    1 Other