BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0.3ML 31GX6MM U-100 INSULIN SYRINGE WALMART

    MDR report key: 10703528 · Received October 20, 2020

    Report

    Report Number
    1920898-2020-01429
    Event Type
    Malfunction
    Date Received
    October 20, 2020
    Date of Event
    September 24, 2020
    Report Date
    November 3, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131138383
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 10/23/2020. H.6. INVESTIGATION: CUSTOMER RETURNED (12) OPEN 3/10CC, 6MM, 31G RELION SYRINGES IN AN OPEN POLY BAG FROM LOT # 9231343. CUSTOMER STATES THAT THE PLUNGER ROD IS DIFFICULT TO MOVE AND HAS TO PUSH HARD CAUSING PET PAIN. ALL RETURNED SYRINGES WERE TESTED AND ALL WERE ABLE TO DRAW AND EXPEL PROPERLY WITHOUT ANY OBSERVED DEFECTS. ALL SAMPLES WERE ALSO ABLE FOR POINT GEOMETRY, LUBE, AND CANNULA OD. ALL OBSERVATIONS FALL WITHIN SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #9231343. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS EXCEPT AS NOTED BELOW. THERE WERE TWO (2) NOTIFICATIONS [200850882, 200850102] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SYRINGE 0.3ML 31G 6MM S/C U-100 RELION HAD DIFFICULT PLUNGER MOVEMENT DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT PLUNGER ROD IS DIFFICULT TO MOVE AND HAS TO PUSH HARD CAUSING PET PAIN. VERBATIM: RELION PET OWNER STATED, PLUNGER ROD IS STIFF AND DIFFICULT TO USE DURING INJECTION STATED, BECAUSE HE AS TO PUSH REALLY HARD ON PLUNGER, ITS CAUSING HIS PET PAIN."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYRINGE 0.3ML 31G 6MM S/C U-100 RELION HAD DIFFICULT PLUNGER MOVEMENT DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT PLUNGER ROD IS DIFFICULT TO MOVE AND HAS TO PUSH HARD CAUSING PET PAIN. VERBATIM: RELION PET OWNER STATED, PLUNGER ROD IS STIFF AND DIFFICULT TO USE DURING INJECTION STATED, BECAUSE HE AS TO PUSH REALLY HARD ON PLUNGER, ITS CAUSING HIS PET PAIN"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1174001 0.3ML 31GX6MM U-100 INSULIN SYRINGE WALMART PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328521 9231343 00681131138383

    Patients

    Seq Age Sex Outcome Treatment
    1