BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5ML 29GA 1/2IN 7BAG 420CAS JP

    MDR report key: 9988715 · Received April 22, 2020

    Report

    Report Number
    1920898-2020-00413
    Event Type
    Malfunction
    Date Received
    April 22, 2020
    Date of Event
    April 6, 2020
    Report Date
    April 7, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: CUSTOMER RETURNED PHOTOS OF A 1/2CC, 12.7MM, 29G SYRINGE WITH A POLY BAG FROM LOT # 9042860. CUSTOMER STATES THAT THE HUB WAS BROKEN. THE PHOTOS WERE EXAMINED AND EXHIBITED BROKEN BARREL TIP. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9042860. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. INVESTIGATION CONCLUSION: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (BROKEN BARREL TIP). ROOT CAUSE DESCRIPTION: "ON (B)(6) 2020, HOLDREGE RECEIVED A COMPLAINT, VIA A PICTURE, FROM MATERIAL 326666, BATCH 9042860. VISUAL INSPECTION OF THE PICTURE FOUND THE BARREL TIP TO BROKEN OFF WHERE IT MEETS THE SHIELD. THE BARREL TIP WAS STILL INSIDE THE SHIELD. PROCESS SUMMARY: AUTOMATIC SYRINGE ASSEMBLY MACHINE, WHICH FEEDS 0.5ML, 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. THERE WERE NO QUALITY NOTIFICATIONS OR MAINTENANCE DISPATCHES DURING THE PRODUCTION OF THIS BATCH THAT PERTAINED TO THIS DEFECT. A ROOT CAUSE CANNOT BE DETERMINED. 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."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DAMAGED PRODUCT WAS FOUND AFTER USE WITH A SYRINGE 0.5ML 29GA 1/2IN 7BAG 420CAS JP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "A HUB WAS BROKEN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452293 SYRINGE 0.5ML 29GA 1/2IN 7BAG 420CAS JP SYRINGE FMF BD MEDICAL - DIABETES CARE 9042860

    Patients

    Seq Age Sex Outcome Treatment
    1 Other