BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5ML 31GA 8MM 10 BAG 500 WAL

    MDR report key: 11829500 · Received May 14, 2021

    Report

    Report Number
    1920898-2021-00559
    Event Type
    Malfunction
    Date Received
    May 14, 2021
    Date of Event
    April 16, 2021
    Report Date
    May 19, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: DEVICE AVAILABLE FOR EVAL YES, RETURNED TO MANUFACTURER ON: (B)(6) 2021. INVESTIGATION SUMMARY: CUSTOMER RETURNED (2) 1/2CC, 8MM, 31G RELION SYRINGES IN AN OPEN POLY BAG FROM LOT # 0083446. CUSTOMER STATES THAT THE SYRINGE HAD A CLEAR LIQUID IN BARREL PRIOR TO INJECTION. BOTH RETURNED SYRINGES WERE EXAMINED AND ONE EXHIBITED CLEAR LIQUID IN THE BARREL. A SMALL PORTION OF THIS MATERIAL WAS REMOVED FROM THE SAMPLE AND PREPARED FOR FTIR SPECTRAL ANALYSIS. THE SPECTRAL ANALYSIS SHOWS THAT THIS MATERIAL IS MOST LIKELY SILICONE. THE REMAINING SYRINGE WAS TESTED AND WAS ABLE TO DRAW AND EXPEL PROPERLY WITHOUT ANY OBSERVED DEFECTS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0083446. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD INSULIN SYRINGES 0.5ML, 31GA 8MM NEEDLES WERE UNABLE OR DIFFICULT TO ASPIRATE AND HAD FOREIGN MATTER IN FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : CONSUMER STATED HE COULD NOT DRAW WITH SYRINGE 1. CONSUMER REPORTED SEEING CLEAR LIQUID IN THE BARREL PRIOR TO INJECTION, DID NOT USE SYRINGE THE SYRINGE AFFECTED. LOT: 0083446. CATALOG: 328509. DATE OF EVENT: UNKNOWN. SAMPLES: YES CL.

    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 IS PENDING 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 2 BD INSULIN SYRINGES 0.5ML, 31GA 8MM NEEDLES WERE UNABLE OR DIFFICULT TO ASPIRATE AND HAD FOREIGN MATTER IN FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : CONSUMER STATED HE COULD NOT DRAW WITH SYRINGE 1. CONSUMER REPORTED SEEING CLEAR LIQUID IN THE BARREL PRIOR TO INJECTION, DID NOT USE SYRINGE THE SYRINGE AFFECTED. LOT: 0083446. CATALOG: 328509. DATE OF EVENT: UNKNOWN. SAMPLES: YES CL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721742 SYRINGE 0.5ML 31GA 8MM 10 BAG 500 WAL PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 0083446

    Patients

    Seq Age Sex Outcome Treatment
    1