BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD IV SET AN122 W/O PUMP T-TYPE

    MDR report key: 8701221 · Received June 14, 2019

    Report

    Report Number
    2243072-2019-01189
    Event Type
    Malfunction
    Date Received
    June 14, 2019
    Date of Event
    May 28, 2019
    Report Date
    July 11, 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

    H.6. INVESTIGATION: INVESTIGATIONS: 1 SAMPLE WAS RETURNED TO SBDM, LOT NUMBER IS 2903152. FROM VISUAL INSPECTION, A BLACK FM IS VISIBLE ON THE TIP. SBDM INITIAL CONCLUSION THE FM WAS A PP CARBIDE. INFRARED SPECTROMETRY (IR) ANALYSIS: BASED ON INFRARED SPECTROMETRY (IR) ANALYSIS OF THE COMPLAINT SAMPLE, THE FM IS FOUND TO BE SAME COMPONENT WITH RAW MATERIAL OF END TIP (POLYPROPYLENE). HOUSE SAMPLE INSPECTION: SBDM INSPECTED 30 PCS OF HOUSE SAMPLES FROM LOT 2903112, 2903152, 2903222, NO ABNORMALITY WAS OBSERVED. DHR REVIEW: SBDM REVIEWED THE MANUFACTURING RECORD OF COMPLAINT SAMPLE, NO ABNORMALITY WAS OBSERVED. ROOT CAUSE: FROM INVESTIGATIONS, THE FM IS CONCLUDED TO BE PP CARBIDE. THE CARBIDE RAW MATERIAL OF I.V SET END TIP COMPONENTS (PP) ARE INJECTED IN THE INJECTION MACHINE ON HIGH TEMPERATURE (200~240). THE LIKELY CAUSE IS PP(RAW MATERIAL OF I.V SET END TIP) CARBIDE MAY BE FORMED IN THE HIGH TEMPERATURE OR GAS EMISSION LINE ON THE MOLD WAS BLOCKED TEMPORARY AND THE GAS FORMED CARBIDE AND IT WAS STUCK INTO THE COMPLAINT I.V SET END TIP WHILE INJECTION PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS FOREIGN MATTER ON IV SET END DURING USE WITH A BD IV SET AN122 W/O PUMP T-TYPE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOREIGN MATTER ON IV SET END-TIP; A BLACK FOREIGN MATTER IS VISIBLE ON THE TIP.

    Additional Manufacturer Narrative · 1

    (B)(4). GREATER ASIA IS AN OEM MANUFACTURING SITE. INITIAL REPORTER PHONE #: UNKNOWN. DEVICE EVALUATED BY MFR: 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 THERE WAS FOREIGN MATTER ON IV SET END DURING USE WITH A BD IV SET AN122 W/O PUMP T-TYPE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOREIGN MATTER ON IV SET END-TIP. A BLACK FOREIGN MATTER IS VISIBLE ON THE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495670 BD IV SET AN122 W/O PUMP T-TYPE IV ADMINISTRATION SET FPA BECTON DICKINSON 2903152

    Patients

    Seq Age Sex Outcome Treatment
    1 Other