BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ IV ADMINISTRATION SET CFN120 BP HS

    MDR report key: 8348676 · Received February 18, 2019

    Report

    Report Number
    2243072-2019-00271
    Event Type
    Malfunction
    Date Received
    February 18, 2019
    Date of Event
    January 29, 2019
    Report Date
    March 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: ONE SAMPLE WAS RETURNED TO HANSCENT, LOT NUMBER IS 20180712. RETENTION SAMPLES INSPECTION: HANSCENT INSPECTED 15 PCS OF RETENTION SAMPLES FROM LOT 20180712, NO ISSUE WAS OBSERVED. DEVICE HISTORY RECORD REVIEW: HANSCENT REVIEWED THE MANUFACTURING RECORD FOR LOT 20180712, NO ABNORMALITY WAS OBSERVED. SGS MATERIAL ANALYSIS: HANSCENT SENT THE SAMPLE TO SGS TO ANALYZE THE FM MATERIAL, THE RESULTS SHOW THE FM MAJOR COMPOSITION WAS PE, WHICH IS THE SPIKE MATERIAL. PROCESS INVESTIGATION: PE MATERIAL WAS ONLY USED DURING SPIKE CAP INJECTION PROCESS. THE PE RAW MATERIAL WAS FED BY THE FEEDING SYSTEM, IT IS UNLIKELY FOR THE RAW MATERIAL TO ATTACH WITH SPIKE. PE MATERIAL MIGHT BE BURNT IN INJECTION MACHINE WITH CONTINUOUSLY HEATING, SMALL PIECE OF BURNT MATERIAL MIGHT FALL DOWN TO INJECTION MACHINE METAL CHUTE. THE INJECTION MACHINE WAS MAINTAINED AND CLEANED DAILY HOWEVER FM MIGHT STILL GENERATE DURING THE MANUFACTURING PERIOD. IT IS NOT FEASIBLE TO CHECK FOR FM TIMELY SINCE THE CHUTE IS TOO DARK. WHEN SPIKE CAP INJECTED OUT AND FELL THROUGH THE CHUTE INTO THE TURNOVER BOX, THE BURNT MATERIAL MIGHT ATTACH INTO THE SPIKE CAP. THE SPIKE AND SPIKE CAP WERE ASSEMBLED TOGETHER DURING THE ASSEMBLY PROCESS, AND THE FM MIGHT ATTACH ON THE SPIKE FROM THE CAP DUE TO THE MACHINE VIBRATION. THE INSPECTOR CONDUCTS 100% FINAL PRODUCT INSPECTION, HOWEVER THERE WILL BE CHALLENGES TO DETECT THE SMALL FM THROUGH THE TRANSLUCENT PLASTIC PACKAGE. ROOT CAUSE: FROM INVESTIGATION, THE FM IS CONCLUDED TO BE PE FROM SGS MATERIAL ANALYZE, WHICH IS THE SPIKE MATERIAL. THE LIKELY CAUSE IS DURING MANUFACTURING, PE MATERIAL MIGHT BE BURNT IN INJECTION MACHINE WITH CONTINUOUSLY HEATING, SMALL PIECE OF BURNT MATERIAL MIGHT FALL DOWN TO INJECTION MACHINE METAL CHUTE. THE INJECTION MACHINE WAS MAINTAINED AND CLEANED DAILY HOWEVER FM MIGHT STILL GENERATE DURING THE MANUFACTURING PERIOD. IT IS NOT FEASIBLE TO CHECK FOR FM TIMELY SINCE THE CHUTE IS TOO DARK. WHEN SPIKE CAP INJECTED OUT AND FELL THROUGH THE CHUTE INTO THE TURNOVER BOX, THE BURNT MATERIAL MIGHT ATTACH INTO THE SPIKE CAP. THE SPIKE AND SPIKE CAP WERE ASSEMBLED TOGETHER DURING THE ASSEMBLY PROCESS, AND THE FM MIGHT ATTACH ON THE SPIKE FROM THE CAP DUE TO THE MACHINE VIBRATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD¿ IV ADMINISTRATION SET CFN120 BP HS EXPERIENCED FOREIGN MATTER CONTAMINATION.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DATE OF EVENT: UNKNOWN. (B)(6). OEM MANUFACTURE: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD¿ IV ADMINISTRATION SET CFN120 BP HS EXPERIENCED FOREIGN MATTER CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139975 BD¿ IV ADMINISTRATION SET CFN120 BP HS INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON 20180712

    Patients

    Seq Age Sex Outcome Treatment
    1 Other