BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION INSULIN SYRINGE

    MDR report key: 10330333 · Received July 27, 2020

    Report

    Report Number
    1920898-2020-00941
    Event Type
    Malfunction
    Date Received
    July 27, 2020
    Date of Event
    July 7, 2020
    Report Date
    August 17, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131311762
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED AS OF 14 AUGUST 2020 THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9231073. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE THREE (3) NOTIFICATIONS [200843441, 200842833, 200833554] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RELION® INSULIN SYRINGE PLUNGER ROD WOULDN'T MOVE DURING THE INJECTION AND PRESSING DOWN ON IT CAUSED IT TO BREAK. LOT#'S 9231073 AND AN UNSPECIFIED LOT WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED -PLUNGER WILL NOT MOVE DURING INJECTING CONSUMER REPORTED WHEN DIFFICULT TO PRESS DOWN PLUNGER THE PLUNGER ROD SOMETIMES BREAKS."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9231073, MEDICAL DEVICE EXPIRATION DATE: NA, DEVICE MANUFACTURE DATE: 2019-10-17, MEDICAL DEVICE LOT #: UNKNOWN, MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: UNKNOWN. 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 RELION® INSULIN SYRINGE PLUNGER ROD WOULDN'T MOVE DURING THE INJECTION AND PRESSING DOWN ON IT CAUSED IT TO BREAK. LOT#'S 9231073 AND AN UNSPECIFIED LOT WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED -PLUNGER WILL NOT MOVE DURING INJECTING. CONSUMER REPORTED WHEN DIFFICULT TO PRESS DOWN PLUNGER THE PLUNGER ROD SOMETIMES BREAKS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789185 RELION INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328509 SEE SECTION H.10. 00681131311762

    Patients

    Seq Age Sex Outcome Treatment
    1 Other