BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION INSULIN SYRINGE

    MDR report key: 11052173 · Received December 21, 2020

    Report

    Report Number
    1920898-2020-01727
    Event Type
    Malfunction
    Date Received
    December 21, 2020
    Date of Event
    November 23, 2020
    Report Date
    February 4, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMI
    UDI-DI
    00681131138345
    PMA / PMN Number
    K170386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0090421. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200879331] NOTED FOR MISSING SCALE LINES. THERE WAS ONE (1) NOTIFICATION [200865384] NOTED FOR MISSING PRINT A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0006079. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200867228] NOTED FOR SCRATCH PRINT. THERE WAS ONE (1) NOTIFICATION [200867227] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0217457. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200899863] NOTED FOR DAMAGED BARREL. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0099968. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200867228] NOTED FOR SCRATCH PRINT. THERE WAS ONE (1) NOTIFICATION [200888551] NOTED FOR MISSING ZERO LINE. THERE WAS ONE (1) NOTIFICATION [200865384] NOTED FOR MISSING PRINT. THERE WAS ONE (1) NOTIFICATION [200867227] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0223926. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200867228] NOTED FOR SCRATCH PRINT. THERE WAS ONE (1) NOTIFICATION [200867227] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IT WAS DIFFICULT TO MEASURE 5 UNITS OF INSULIN WITH RELION® INSULIN SYRINGE SCALES 1 ML MARKINGS. THIS OCCURRED WITH SYRINGES IN LOTS 0223926, 0099968, 0217457, 0006079, AND 0090421. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PET OWNER STATED HER DOG TAKES 5 UNITS OF INSULIN AND THE CURRENT SYRINGES ARE IN INCREMENTS OF 10 WHICH SHE CAN NOT USE. STATED IT IS HARD TO MEAUSURE 5 UNITS WITH THE 1 ML SYRINGES. STATED SHE PURCHASED 10 BOXES AND DID NOT REALIZE HOW THE SCALE MARKINGS ARE WITH THE 1ML SYRINGES. STATED HER PET WAS PREVIOUSLY USING THE 3/10 ML, 6MM SYRINGES."

    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 #: 0223926, MEDICAL DEVICE EXPIRATION DATE: NA, DEVICE MANUFACTURE DATE: 2020-08-10. MEDICAL DEVICE LOT #: 0099968, MEDICAL DEVICE EXPIRATION DATE: NA, DEVICE MANUFACTURE DATE: 2020-06-22. MEDICAL DEVICE LOT #: 0217457, MEDICAL DEVICE EXPIRATION DATE: NA, DEVICE MANUFACTURE DATE: 2020-08-04. MEDICAL DEVICE LOT #: 0006079, MEDICAL DEVICE EXPIRATION DATE: NA, DEVICE MANUFACTURE DATE: 2020-02-26. MEDICAL DEVICE LOT #: 0090421, MEDICAL DEVICE EXPIRATION DATE: NA, DEVICE MANUFACTURE DATE: 2020-05-01. 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 IT WAS DIFFICULT TO MEASURE 5 UNITS OF INSULIN WITH RELION® INSULIN SYRINGE SCALES 1 ML MARKINGS. THIS OCCURRED WITH SYRINGES IN LOTS 0223926, 0099968, 0217457, 0006079, AND 0090421. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PET OWNER STATED HER DOG TAKES 5 UNITS OF INSULIN AND THE CURRENT SYRINGES ARE IN INCREMENTS OF 10 WHICH SHE CAN NOT USE. STATED IT IS HARD TO MEASURE 5 UNITS WITH THE 1 ML SYRINGES. STATED SHE PURCHASED 10 BOXES AND DID NOT REALIZE HOW THE SCALE MARKINGS ARE WITH THE 1ML SYRINGES. STATED HER PET WAS PREVIOUSLY USING THE 3/10 ML, 6MM SYRINGES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1512287 RELION INSULIN SYRINGE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL - DIABETES CARE 328519 SEE SECTION H.10. 00681131138345

    Patients

    Seq Age Sex Outcome Treatment
    1