BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION INSULIN SYRINGE

    MDR report key: 11713427 · Received April 23, 2021

    Report

    Report Number
    1920898-2021-00452
    Event Type
    Malfunction
    Date Received
    April 23, 2021
    Date of Event
    March 26, 2021
    Report Date
    May 14, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131311786
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-04-30. H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED FOUR SYRINGES WITH 0.3ML GRADUATION MARKS. WHEN ATTEMPTED, WATER COULD NOT BE DRAWN INTO ONE OF THE FOUR SYRINGES. THIS SYRINGE WAS INSPECTED UNDER A MICROSCOPE AND NO DEFECTS WERE IMMEDIATELY VISIBLE. A WIRE WAS THREADED INTO THE DISTAL TIP OF THE CANNULA. THE WIRE REACHED SEVERAL MILLIMETERS INTO THE LENGTH OF THE CANNULA BEFORE STOPPING. THE WIRE COULD NOT BE USED TO DISLODGE THE OBSTRUCTION. THE OBSTRUCTION IS LIKELY ADHESIVE BASED ON ITS LOCATION AND DURABILITY. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0160001. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. BASED ON THE PHOTOS RECEIVED, BD WAS UNABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF THE SYRINGE NOT DRAWING IN ONE OF THE FOUR RETURNED SYRINGES. ROOT CAUSE CANNOT BE DETERMINED FOR THIS COMPLAINT. H3 OTHER TEXT: SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INSULIN WAS UNABLE TO BE DRAWN WITH 10 RELION¿ INSULIN SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT 10 SYRINGES COULD NOT DRAW UP INSULIN.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: NA. 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 INSULIN WAS UNABLE TO BE DRAWN WITH 10 RELION¿ INSULIN SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT 10 SYRINGES COULD NOT DRAW UP INSULIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611141 RELION INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328512 0160001 00681131311786

    Patients

    Seq Age Sex Outcome Treatment
    1