BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5ML 29GA 12.7MM

    MDR report key: 8902433 · Received August 16, 2019

    Report

    Report Number
    1920898-2019-00832
    Event Type
    Malfunction
    Date Received
    August 16, 2019
    Date of Event
    July 24, 2019
    Report Date
    August 23, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903248926
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED PHOTOS OF A SYRINGE WITH THE BLISTER PACK FROM LOT # 8211735. CUSTOMER STATES THAT THE PLUNGER IS DEFECTIVE. THE PHOTOS WERE EXAMINED AND EXHIBITED A DEFORMED STOPPER IN THE BARREL. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8211735. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. 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 (DEFORMED STOPPER). AS PER INVESTIGATION COMPLETED BY MANUFACTURING, "ON 02AUG2019, HOLDREGE RECEIVED A COMPLAINT, VIA PICTURES, FOR MATERIAL 324892, BATCH 8211735. VISUAL INSPECTION OF THE PICTURES SHOWS THE SYRINGE FROM THREE DIFFERENT ANGLES. THE STOPPER IS SMEARED AGAINST THE SIDE OF THE PLUNGER. THE TIP OF THE PLUNGER LOOKS INTACT AND UNDAMAGED. 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. THERE WERE NO QUALITY NOTIFICATIONS OR MAINTENANCE DISPATCHES FOR THIS ISSUE DURING THE PRODUCTION OF THIS SYRINGE. 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 · 0

    IT WAS REPORTED THAT A DEFECTIVE PLUNGER WAS FOUND BEFORE USE WITH A SYRINGE 0.5ML 29GA 12.7MM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "DEFECT PLUNGER".

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DEFECTIVE PLUNGER WAS FOUND BEFORE USE WITH A SYRINGE 0.5 ML 29GA 12.7 MM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "DEFECT PLUNGER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695087 SYRINGE 0.5ML 29GA 12.7MM SYRINGE FMF BD MEDICAL - DIABETES CARE 8211735 00382903248926

    Patients

    Seq Age Sex Outcome Treatment
    1 Other