BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION INSULIN SYRINGE

    MDR report key: 9309148 · Received November 12, 2019

    Report

    Report Number
    1920898-2019-01265
    Event Type
    Malfunction
    Date Received
    November 12, 2019
    Date of Event
    October 25, 2019
    Report Date
    October 29, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131138383
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: N/A. INVESTIGATION SUMMARY: NO SAMPLES WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9140674. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS EXCEPT AS NOTED BELOW. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. INVESTIGATION CONCLUSION: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RELION® INSULIN SYRINGE PLUNGER WOULD NOT PULL BACK DURING USE, AND REMOVING THE PLUNGER CAP CAUSED THE WHOLE ROD TO SEPARATE FROM THE BARREL. THIS EVENT OCCURRED ON 7 SEPARATE OCCASIONS, BUT THE DATES ARE UNKNOWN. ADDITIONALLY, IT WAS REPORTED THAT THE NEEDLE HUB SEPARATED FROM THE SYRINGE DURING USE AND REMAINED IN THE SHIELD. THIS EVENT OCCURRED ON 4 SEPARATE OCCASIONS, BUT THE DATES ARE UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER LEFT VOICEMAIL REPORTING THE SYRINGE SHE BROUGHT 31G, 6MM,3/10 ML CANNOT PULL BACK THE PLUNGER. IT HAPPENED WITH 2 PACKAGES, SHE ALSO REPORTED WHEN SHE OPENED THE ORANGE CAP NEEDLE STAYED INSIDE ITS STUCK INSIDE." "WHEN SHE REMOVES THE PLUNGER CAP OFF THE ENTIRE PLUNGER ROD COMES OUT OF THE BARREL WITH THE STOPPER." "NEEDLE WITH HUB STAYS INSIDE THE NEEDLE SHIELD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1103270 RELION INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 9140674 00681131138383

    Patients

    Seq Age Sex Outcome Treatment
    1 Other