BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31GA 8MM

    MDR report key: 11573144 · Received March 25, 2021

    Report

    Report Number
    1920898-2021-00348
    Event Type
    Malfunction
    Date Received
    March 25, 2021
    Date of Event
    March 2, 2021
    Report Date
    April 19, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131311786
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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: 3/18/2021. H.6. INVESTIGATION: CUSTOMER RETURNED SINGLE 0.3ML SYRINGE WITH NO POUCH FOR IDENTIFICATION. IT WAS NOTED THAT WATER COULD NOT BE DRAWN INTO THE BARREL OF THE SYRINGE DURING TESTING. A WIRE WAS THEN INSERTED INTO THE DISTAL TIP OF THE NEEDLE. WHILE THE WIRE COULD ENTER AND PASS THROUGH A PORTION OF THE NEEDLE¿S CANNULA, IT WOULD NOT PASS THROUGH THE FULL LENGTH OF THE CANNULA. THE WIRE COULD NOT FORCEFULLY DISLODGE THE OBSTRUCTION. IT IS BELIEVED THAT ADHESIVE MAY BE BLOCKING THE PATH OF FLUID THROUGH THE CANNULA. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0160001. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. ROOT CAUSE CANNOT BE DETERMINED FOR THIS COMPLAINT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE 0.3ML 31GA 8MM WAS UNABLE OR DIFFICULT TO ASPIRATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED THAT THE NEEDLE WILL NOT DRAW INSULIN. LOT #: 0160001; CATALOG #: 328512; DATE OF EVENT: UNKNOWN.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: NA. 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 THE SYRINGE 0.3ML 31GA 8MM WAS UNABLE OR DIFFICULT TO ASPIRATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED THAT THE NEEDLE WILL NOT DRAW INSULIN. LOT #: 0160001. CATALOG #: 328512. DATE OF EVENT: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469628 SYRINGE 0.3ML 31GA 8MM PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328512 0160001 00681131311786

    Patients

    Seq Age Sex Outcome Treatment
    1