BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELION INSULIN SYRINGE

    MDR report key: 10074991 · Received May 20, 2020

    Report

    Report Number
    1920898-2020-00548
    Event Type
    Injury
    Date Received
    May 20, 2020
    Date of Event
    April 28, 2020
    Report Date
    April 29, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131311762
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: CUSTOMER RETURNED SAMPLES FROM LOT # 9154593 WHICH WILL BE INVESTIGATED UNDER COMPLAINT (B)(4). NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED FROM LOT # 9210536 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# 9210536. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200837053] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. CONCLUSION: AS NO SAMPLES AND/OR PHOTO(S) WERE RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. ROOT CAUSE: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. RATIONALE: BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME

    Description of Event or Problem · 1

    IT WAS REPORTED DURING USE THE RELION® INSULIN SYRINGE THE CONSUMER EXPERIENCED SERIOUS INJURY (MEDICAL INTERVENTION). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER MAY HAVE EXPERIENCED AN ALLERGIC REACTION TO RELION SYRINGES. CONSUMER STATED THAT THERE IS PAIN/BURNING AT THE INJECTION SITE DURING INJECTION, SAID IT HAPPENS WHEN SHE INSERTS THE NEEDLE, JUST BEFORE SHE RELEASES THE INSULIN. ALSO STATED THAT SORES DEVELOPED AROUND THE INJECTION SITE AFTER INJECTION. CONSUMER STATED THAT SHE NOTICED THE BURNING OVER THE YEARS BUT IT SEEMED TO HAVE GOTTEN MUCH WORSE A FEW MONTHS AGO WHEN SHE HAD A SURGERY TO HAVE METAL PLATES AND SCREWS PUT IN HER NECK. CONSUMER WAS PRESCRIBED MEDICATION (LEVOCETIRINE AND SOMETHING ELSE) TO RELIEVE THE PAIN AND CLEAR UP THE SORES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540118 RELION INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328509 9210536 00681131311762

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention