BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1.0ML 30GA 8MM 7BAG 420CAS JP

    MDR report key: 9555242 · Received January 6, 2020

    Report

    Report Number
    1920898-2020-00001
    Event Type
    Malfunction
    Date Received
    January 6, 2020
    Date of Event
    December 12, 2019
    Report Date
    January 8, 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 · 0

    H.6. INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) LOOSE 1CC, 8MM SYRINGE. CUSTOMER STATES THAT THERE IS A SCRATCH ON THE PLUNGER AND IT IS BENT. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED A DAMAGED AND BENT PLUNGER ROD. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 8162853. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE THREE (3) NOTIFICATIONS [200769369, 200768465, 200768576,] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. THERE WAS ONE (1) NOTIFICATION [200768467] NOTED FOR SMEARED STOPPERS. 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. AS PER INVESTIGATION COMPLETED BY MANUFACTURING, "VISUAL INSPECTION OF ATTACHED PHOTOS FOR BATCH 8162853, THE PLUNGER WAS DAMAGED WHICH LOOKS LIKE A SCRAPE ON THE SIDE OF THE PLUNGER. AUTOMATIC SYRINGE ASSEMBLY MACHINE, WHICH FEEDS 1CC/ML, SYRINGE COMPONENTS (BARREL, STOPPER, PLUNGER) AND ASSEMBLES THESE COMPONENTS. THIS MACHINE CONSISTS OF A BARREL-CLEANING DIAL, LUBRICATION DIAL, ONE PLUNGER/STOPPER ASSEMBLY DIAL AND ONE SYRINGE ASSEMBLY DIAL AND VARIOUS INSPECTION AND TRANSFER DIALS. THERE WERE NO QUALITY NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. THERE WERE TWO MAINTENANCE DISPATCHES (34727) FOR LOTS OF MAIN DIAL OUT FEED JAMS. THE CORRECTIVE ACTION FOR THAT WAS ADJUSTED THE AIR JET SO PLUNGERS WOULD KEEP UP BETTER. (34598) FOR BREAKING PLUNGERS OFF. THE CORRECTIVE ACTION WAS ADJUST FEEDER BIN TO CORRECT LEVEL SO RAIL WOULD GET ENOUGH PLUNGERS TO FEED IT. 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 PLUNGER ISSUES WERE FOUND BEFORE USE WITH A SYRINGE 1.0ML 30GA 8MM 7BAG 420CAS JP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "SCRATCH ON THE PLUNGER AND IT IS BENT."

    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 PLUNGER ISSUES WERE FOUND BEFORE USE WITH A SYRINGE 1.0ML 30GA 8MM 7BAG 420CAS JP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "SCRATCH ON THE PLUNGER AND IT IS BENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19010 SYRINGE 1.0ML 30GA 8MM 7BAG 420CAS JP SYRINGE FMF BD MEDICAL - DIABETES CARE 8162853

    Patients

    Seq Age Sex Outcome Treatment
    1 Other