BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION INSULIN SYRINGE

    MDR report key: 10022500 · Received May 4, 2020

    Report

    Report Number
    1920898-2020-00466
    Event Type
    Malfunction
    Date Received
    May 4, 2020
    Date of Event
    April 13, 2020
    Report Date
    May 14, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131138345
    PMA / PMN Number
    K170386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY : NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED AS OF 14 MAY 2020 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# 9210965. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. 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. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PLUNGER ISSUES OCCURRED DURING USE WITH A RELION® INSULIN SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "CONSUMER REPORTED PLUNGERS HARD TO MOVE DURING INJECTION. DRAWING UP IS FINE - NO ISSUES DRAWING UP. CONSUMER DOES NOT REUSE OR STORE THE 70/30 INSULIN IN SYRINGE. PLACES EQUAL AMOUNTS OF AIR VERSUS INSULIN, 80 UNITS. LOT #: 9210965 CATALOG#: 328519 DATE OF EVENT: LAST 10- 12 BOXES. UNKNOWN LOT NUMBERS. SAME ITEM SIZE/NUMBER. CLAIMS 90 PERCENT OF THE BOX. UNKNOWN DATES. SAMPLES STATUS FROM THIS CURRENT BOX YES LOT # 9210965."

    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 #: 9210965. MEDICAL DEVICE EXPIRATION DATE: N/A. DEVICE MANUFACTURE DATE: 2019-08-28. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PLUNGER ISSUES OCCURRED DURING USE WITH A RELION® INSULIN SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "CONSUMER REPORTED PLUNGERS HARD TO MOVE DURING INJECTION. DRAWING UP IS FINE - NO ISSUES DRAWING UP. CONSUMER DOES NOT REUSE OR STORE THE 70/30 INSULIN IN SYRINGE. PLACES EQUAL AMOUNTS OF AIR VERSUS INSULIN, 80 UNITS. LOT #: 9210965. CATALOG#: 328519. DATE OF EVENT: LAST 10- 12 BOXES. UNKNOWN LOT NUMBERS. SAME ITEM SIZE/NUMBER. CLAIMS 90 PERCENT OF THE BOX. UNKNOWN DATES. SAMPLES STATUS FROM THIS CURRENT BOX YES LOT # 9210965."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483553 RELION INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328519 SEE. H.10 00681131138345

    Patients

    Seq Age Sex Outcome Treatment
    1 Other