BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 29GA 1/2IN 7BAG 420CAS JP

    MDR report key: 10089390 · Received May 26, 2020

    Report

    Report Number
    1920898-2020-00566
    Event Type
    Malfunction
    Date Received
    May 26, 2020
    Date of Event
    May 11, 2020
    Report Date
    May 11, 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

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 3RD RELATED COMPLAINT FOR NEEDLE HUB SEPARATES ON LOT # 9231316. INVESTIGATION SUMMARY: CUSTOMER RETURNED PHOTOS OF A 3/10CC, 12.7MM, 29G SYRINGE WITH A POLY BAG FROM LOT # 9231316. CUSTOMER STATES THAT THE HUB SEPARATES. THE PHOTOS WERE EXAMINED AND EXHIBITED THE HUB-NEEDLE/SHIELD ASSEMBLY SEPARATED FROM THE BARREL. MANUFACTURING (HOLDREGE) WILL BE NOTIFIED OF THIS ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9231316. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [(B)(4)] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. INVESTIGATION 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. 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: AS PER INVESTIGATION COMPLETED BY MANUFACTURING UNDER INVESTIGATION CHILD (B)(4), ON (B)(6) 2020, HOLDREGE RECEIVED PHOTO COMPLAINT. A VISUAL EVALUATION OF PHOTO FOUND (1) SYRINGE WITH NO NEEDLE ASSEMBLY ATTACHED. THERE DID NOT APPEAR TO BE ANY DAMAGE TO THE TIP OF THE BARREL, OR ANYWHERE ON THE SYRINGE. THERE DID NOT APPEAR TO BE ANY CORE PIN DAMAGE. PROCESS SUMMARY: AUTOMATIC SYRINGE ASSEMBLY MACHINE, WHICH FEEDS 3/10CC, SYRINGE COMPONENTS (BARREL, STOPPER, PLUNGER, NEEDLE ASSEMBLY & CAP) AND ASSEMBLES THESE COMPONENTS. THIS MACHINE CONSISTS OF A BARREL CLEANING DIAL, LUBRICATION DIAL, PLUNGER/STOPPER ASSEMBLY DIAL, SYRINGE ASSEMBLY DIAL, AND VARIOUS INSPECTIONS AND TRANSFER DIALS. DHR, L2L DISPATCHES, AND LOGBOOK ENTRIES WERE LOOKED AT, NOTHING PERTAINING TO THIS DEFECT WAS FOUND. ROOT CAUSE FOR THIS DEFECT CANNOT BE DETERMINED. TIP-2019-37 WAS IMPLEMENTED ON (B)(6) 2019 FOR INCREASED SAMPLING FOR NEEDLE HUB SEPARATES IN 0.3ML. CAPA(B)(4) HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 0.3ML 29GA 1/2IN 7BAG 420CAS JP HUB SEPARATED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER (B)(6), HUB SEPARATES OCCURRED ON (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553535 SYRINGE 0.3ML 29GA 1/2IN 7BAG 420CAS JP SYRINGE FMF BD MEDICAL - DIABETES CARE 9231316

    Patients

    Seq Age Sex Outcome Treatment
    1 Other