BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31GA 8MM 10BAG 500 WAL

    MDR report key: 11668377 · Received April 14, 2021

    Report

    Report Number
    1920898-2021-00403
    Event Type
    Malfunction
    Date Received
    April 14, 2021
    Date of Event
    March 16, 2021
    Report Date
    May 14, 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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-04-30. H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) LOOSE 3/10CC, 8MM SYRINGE. CUSTOMER STATES THAT THEY CANNOT PULL THE PLUNGER BACK. THE RETURNED SYRINGE WAS TESTED AND WAS NOT ABLE TO DRAW PROPERLY. THE SAMPLE WAS THEN WIRED AND THE WIRE WAS NOT ABLE TO PASS THROUGH THE CANNULA. THIS INDICATES THAT THERE IS AN ADHESIVE CLOG IN 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: THE CAMERA WAS OUT OF ADJUSTMENT. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SYRINGE 0.3ML 31GA 8MM 10BAG 500 WAL HAD DIFFICULT PLUNGER MOVEMENT AND WAS UNABLE TO ASPIRATE DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE CONSUMER CAN NOT DRAW THE INSULIN AND CAN NOT PULL THE PLUNGER BACK. VERBATIM: RELION SPOUSE OF CONSUMER REPORTED, HUSBAND CANNOT DRAW WITH SYRINGE STATED, HE CANNOT PULL BACK THE PLUNGER."

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYRINGE 0.3ML 31GA 8MM 10BAG 500 WAL HAD DIFFICULT PLUNGER MOVEMENT AND WAS UNABLE TO ASPIRATE DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE CONSUMER CAN NOT DRAW THE INSULIN AND CAN NOT PULL THE PLUNGER BACK. VERBATIM: RELION SPOUSE OF CONSUMER REPORTED, HUSBAND CANNOT DRAW WITH SYRINGE STATED, HE CANNOT PULL BACK THE PLUNGER".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563937 SYRINGE 0.3ML 31GA 8MM 10BAG 500 WAL PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328512 0160001 00681131311786

    Patients

    Seq Age Sex Outcome Treatment
    1