BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ PROTECTOR P50J

    MDR report key: 7413317 · Received April 10, 2018

    Report

    Report Number
    3003152976-2018-00133
    Event Type
    Malfunction
    Date Received
    April 10, 2018
    Date of Event
    March 23, 2018
    Report Date
    May 16, 2018
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    LHI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: LIQUID IN EXPANSION CHAMBER THE SAMPLE WAS EVALUATED BY JFR LAB. ACCORDING TO THE REPORT RECEIVED ON (B)(6) 2018, THE DEFECT IS CONFIRMED: THERE IS LEAK TROUGH THE HYDROPHOBIC FILTER. TWO RETAINED SAMPLES WERE TAKING FOR EVALUATION. VISUAL INSPECTION SHOWS NO DEFECTS. HYDROPHOBIC FILTER LEAKAGE WAS PERFORMED ACCORDING PH-302 (CURRENT VERSION) AND NO LEAK WAS FOUND. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCE'S ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF THIS BATCH. INVESTIGATION CONCLUSION: THE DEFECT IS CONFIRMED IN THE SAMPLE EVALUATED BY JFRL. HOWEVER, IT WAS NO POSSIBLE TO DUPLICATE IT WITH THE RETAINED SAMPLES. DHR WAS REVIEWED AS WELL AND NO QN'S OR OTHER DEFECTS WERE FOUND. NO LEAK WAS FOUND DURING MANUFACTURING PROCESS.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD PHASEAL¿ PROTECTOR P50J LEAKED INTO THE BLADDER DURING USE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253736 BD PHASEAL¿ PROTECTOR P50J ADMINISTRATION SET LHI BECTON DICKINSON, S.A. 1703107

    Patients

    Seq Age Sex Outcome Treatment
    1 Other