BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ IV SET S404F W/O BP Y-CONN EV

    MDR report key: 7609926 · Received June 18, 2018

    Report

    Report Number
    2243072-2018-00370
    Event Type
    Malfunction
    Date Received
    June 18, 2018
    Date of Event
    May 4, 2018
    Report Date
    July 11, 2018
    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

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLES RETURNED TO SANXIN. INVESTIGATION: DEVICE HISOTRY RECORD REVIEW: SANXIN RECHECK SAME LOT G1170726 IN PROCESS RECORD, LOT SIZE (B)(4) PCS, ACCORDINGLY TO SANXIN SEMI FINISHED PRODUCT INSPECTION, THE AIR FILTER WATER RESISTANT CRITERIA SAMPLE LEVEL: 1 CAVITY [0 1], INSPECT 1 TIME, NO LEAKAGE FOUND. SANXIN RECHECK SAME LOT G1170726 FINISHED PRODUCT, LOT SIZE (B)(4) PCS, LEAKAGE PERFORMANCE CRITERIA SAMPLING LEVEL S-2, AQL1.0, SAMPLING PLAN: 13 [0 1], INSPECTED 13 PCS, NO LEAKAGE FOUND. SANXIN INSPECTED 5 PCS RETENTION SAMPLES, NO LEAKAGE WERE FOUND. INVESTIGATION CONCLUSION: LIKELY ROOT CAUSE: SINCE NO SAMPLE RETURNED, THE POTENTIAL ROOT CAUSE COULD BE: DURING AIR FILTER ASSEMBLY PROCESS, THE TOOLING POSITION FOR THE SPIKE IS DEVIATED, CAUSING THE AIR FILTER UNABLE TO MATCHED WITH THE AIR VENT COMPLETELY. THIS SUB ASSEMBLY THEN GET TRANSFERRED INTO THE NEXT PROCESS, SUBSEQUENTLY THE AIR FILTER IS NOT WELDED ON THE SPIKE. SINCE THE AIR FILTER IS WHITE IN COLOR, SAME AS SPIKE, THERE ARE CHANCES THAT DURING THE 100% INSPECTION, DUE TO FATIGUE, THE INSPECTORS DID NOT CAPTURED THIS NON CONFORMANCE AND ALLOWED THE UNQUALIFIED PRODUCT TO PASS THROUGH THE INSPECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD¿ IV SET S404F W/O BP Y-CONN EV LEAKED DURING USE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTIONS.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS SEOUL. THIS SITE IS NOT REGISTERED WITH THE FDA. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED IN SECTIONS AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER (B)(6). 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 A BD¿ IV SET S404F W/O BP Y-CONN EV LEAKED DURING USE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451148 BD¿ IV SET S404F W/O BP Y-CONN EV INTRAVASCULAR ADMINISTRATION SET FOZ BECTON DICKINSON G1170726

    Patients

    Seq Age Sex Outcome Treatment
    1 Other