BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IV SET AN115 23G 1IN BP

    MDR report key: 8856452 · Received August 2, 2019

    Report

    Report Number
    2243072-2019-01583
    Event Type
    Malfunction
    Date Received
    August 2, 2019
    Date of Event
    July 17, 2019
    Report Date
    August 19, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: INVESTIGATIONS: 1 SAMPLE WAS RETURNED TO SBDM, LOT NUMBER IS 2904181. FROM VISUAL INSPECTION, THERE IS FM ON THE SPIKE. INFRARED SPECTROMETRY (IR) ANALYSIS: FROM IR ANALYSIS, THE FM IS DETERMINED TO BE RAW MATERIAL OF SPIKE. HOUSE SAMPLE INSPECTION: SBDM INSPECTED 30 PCS HOUSE SAMPLES FROM LOTS 2904106, 2904181, 2904181, NO ABNORMALITY OBSERVED. DHR REVIEW: SBDM REVIEWED THE MANUFACTURING RECORD FOR THE COMPLAINT SAMPLE, NO ABNORMALITY OBSERVED. ROOT CAUSE: FROM INVESTIGATIONS, THE RAW MATERIAL OF I.V SET SPIKE COMPONENTS ARE INJECTED IN THE INJECTION MACHINE ON HIGH TEMPERATURE (200~240). THE LIKELY CAUSE IS THAT ABS(RAW MATERIAL OF I.V SET SPIKE) CARBIDE MAY BE FORMED IN THE HIGH TEMPERATURE OR GAS EMISSION LINE ON THE INJECTION MOLD WAS BLOCKED TEMPORARY AND THE GAS FORMED CARBIDE. SUBSEQUENTLY, THE CARBIDE WAS INJECTED WITH THE SPIKE OF THE COMPLAINT I.V SET DURING INJECTION PROCESS. THE PROCESS INSPECTOR DID NOT NOTICE IT WHILE MANUFACTURING PROCESS AND IT CAUSED THIS COMPLAINT CASE. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IV SET AN115 23G 1IN BP HAD FOREIGN MATTER ON IT. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOREIGN MATERIAL ON THE SPIKE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EVALUATED BY MFR: 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 IV SET AN115 23G 1IN BP HAD FOREIGN MATTER ON IT. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOREIGN MATERIAL ON THE SPIKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647838 IV SET AN115 23G 1IN BP CATHETER FOZ BECTON DICKINSON 2904181

    Patients

    Seq Age Sex Outcome Treatment
    1 Other