BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IV SET AN125 W/O BP 200C

    MDR report key: 8895772 · Received August 14, 2019

    Report

    Report Number
    2243072-2019-01707
    Event Type
    Malfunction
    Date Received
    August 14, 2019
    Date of Event
    July 29, 2019
    Report Date
    September 13, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    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

    INVESTIGATION: INVESTIGATIONS: 1 SAMPLE WAS RETURNED TO SBDM, LOT NUMBER IS 2903284. INFRARED SPECTROMETRY (IR) ANALYSIS: FROM IR ANALYSIS, THE FM ON THE SPIKE WAS DETERMINE TO BE PART OF ABS, WHICH IS THE RAW MATERIAL OF SPIKE. HOUSE SAMPLE INSPECTION: SBDM INSPECTED 30 PCS OF HOUSE SAMPLES FROM LOTS 2903281, 2903284 AND 2904011, NO ABNORMALITY OBSERVED. DHR REVIEW: SBDM REVIEWED THE MANUFACTURING RECORD AND NO ABNORMALITY OBSERVED. CUSTOMER COMPLAINT RECORD REVIEW: SBDM REVIEWED CUSTOMER COMPLAINT RECORD REVIEW, THERE IS NO SIMILAR ISSUE FROM OTHER CUSTOMERS. ROOT CAUSE: FROM INVESTIGATIONS, THE RAW MATERIAL OF I.V SET SPIKE COMPONENTS ARE INJECTED IN THE INJECTION MACHINE ON HIGH TEMPERATURE (200~240). IT IS LIKELY 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, AND THE PROCESS INSPECTOR DID NOT CAPTURE THIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IV SET AN125 W/O BP 200C HAD FOREIGN MATTER. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOREIGN MATTER ON IV SET SPIKE.

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. 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. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IV SET AN125 W/O BP 200C HAD FOREIGN MATTER. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOREIGN MATTER ON IV SET SPIKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685423 IV SET AN125 W/O BP 200C CATHETER FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other