BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 30GA 8MM 10BAG 500CAS AP

    MDR report key: 10016420 · Received April 30, 2020

    Report

    Report Number
    1920898-2020-00451
    Event Type
    Malfunction
    Date Received
    April 30, 2020
    Date of Event
    April 12, 2020
    Report Date
    June 5, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO SAMPLES WERE RETURNED AS OF 5 JUNE 2020 THEREFORE THE INVESTIGATION WAS PERFORMED BASED ON THE PHOTOS PROVIDED. FOUR (4) PHOTOS OF 30GX8MM, 0.3ML BD INSULIN SYRINGES WERE PROVIDED. CONSUMER REPORTED TOP OF SYRINGE HAS GOT WATER DROP WHEN PRESS PITTON. ALL FOUR PHOTOS WERE REVIEWED AND A MATERIAL NEAR THE TIP OF THE CANNULA OF FOUR SYRINGES WAS OBSERVED, HOWEVER, A ROOT CAUSE COULD NOT BE DETERMINED FROM THE PHOTOS ALONE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #9063722. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS EXCEPT AS NOTED BELOW. THERE WAS ONE (1) NOTIFICATION [200812438] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED BEFORE USE THE SYRINGE 0.3ML 30GA 8MM 10BAG 500CAS AP HAD FOREIGN MATTER ON THE DEVICE CANNULA/IN FLUID PATH. THIS EVENT OCCURRED 50 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TOP OF SYRINGE HAS GOT WATER DROP WHEN PRESS PISTON. PATIENT USED SYRINGE TO INJECT BUT THEY SAW A WATER DROP WHEN THEY PRESSED THE PISTON, SO THEY "DIDN'T" USE THIS SYRINGE." EVENT TRANSLATED FROM VIETNAMESE TO ENGLISH.

    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 BEFORE USE THE SYRINGE 0.3ML 30GA 8MM 10BAG 500CAS AP HAD FOREIGN MATTER ON THE DEVICE CANNULA/IN FLUID PATH. THIS EVENT OCCURRED 50 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TOP OF SYRINGE HAS GOT WATER DROP WHEN PRESS PISTON. PATIENT USED SYRINGE TO INJECT BUT THEY SAW A WATER DROP WHEN THEY PRESSED THE PISTON, SO THEY DIDNT USE THIS SYRINGE." EVENT TRANSLATED FROM VIETNAMESE TO ENGLISH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476375 SYRINGE 0.3ML 30GA 8MM 10BAG 500CAS AP PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 9063722

    Patients

    Seq Age Sex Outcome Treatment
    1 Other