BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK SYRINGE

    MDR report key: 10269471 · Received July 14, 2020

    Report

    Report Number
    1920898-2020-00846
    Event Type
    Malfunction
    Date Received
    July 14, 2020
    Date of Event
    June 22, 2020
    Report Date
    July 28, 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 · 0

    H.6. INVESTIGATION SUMMARY: CUSTOMER RETURNED ONE (1) LOOSE 29GX12.7MM, 1ML BD INSULIN SYRINGE. CUSTOMER IS COMPLAINING THAT IT IS DIFFICULT TO USE SOME PRODUCTS DUE TO TIGHT GASKET. THE RETURNED SYRINGE WAS EXAMINED, AND IT WAS OBSERVED THAT THE PLUNGER ROD WAS SEPARATED FROM THE RUBBER STOPPER. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9081523. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (PLUNGER ROD SEPARATES). A ROOT CAUSE CANNOT BE DETERMINED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ SYRINGE HAD DIFFICULT PLUNGER MOVEMENT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "CUSTOMER IS COMPLAINING THAT IT IS DIFFICULT TO USE SOME PRODUCTS DUE TO TIGHT GASKET. THE CUSTOMER HAS EXPERIENCED THE SAME INCIDENT BEFORE."

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ SYRINGE HAD DIFFICULT PLUNGER MOVEMENT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "CUSTOMER IS COMPLAINING THAT IT IS DIFFICULT TO USE SOME PRODUCTS DUE TO TIGHT GASKET. THE CUSTOMER HAS EXPERIENCED THE SAME INCIDENT BEFORE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733065 BD PLASTIPAK SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 9081523

    Patients

    Seq Age Sex Outcome Treatment
    1 Other