BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ PROTECTOR P15J

    MDR report key: 8203005 · Received December 28, 2018

    Report

    Report Number
    3003152976-2018-00570
    Event Type
    Malfunction
    Date Received
    December 28, 2018
    Date of Event
    December 7, 2018
    Report Date
    January 22, 2019
    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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT LEAKAGE OCCURRED BETWEEN THE BD PHASEAL¿ PROTECTOR P15J AND VIAL. THIS OCCURRED ON 3 SEPARATE OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD WAS PERFORMED FOR THE PROVIDED LOT NUMBER (1704120) AND THE REVIEW DID NOT REVEAL ANY QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS INCIDENT. THREE SAMPLES WERE EVALUATED BY JFR LAB. LEAK BETWEEN PROTECTOR AND VIAL WAS FOUND IN ONE OF THE SAMPLES. AFTER HAVING RECONNECTED THE SAMPLE, NO LEAK FOUND. LEAK BETWEEN PROTECTOR AND VIAL ¿THREE SAMPLES WERE EVALUATED BY JFR LAB. ¿SAMPLE 1 AND 3 WORKED PROPERLY AND NO LEAK WAS FOUND. ¿FOR SAMPLE 2, AIR LEAKAGE WAS FOUND BETWEEN PROTECTOR AND VIAL. DRUG LEAK WAS FOUND BETWEEN THE PROTECTOR AND THE VIAL AS WELL. ¿SAMPLE 2 WAS RECONNECTED TO THE VIAL AGAIN. AFTER THAT, THE PROTECTOR WORKED PROPERLY AND NO LEAK WAS FOUND. INSPECTIONS AND TESTS IN MANUFACTURING AREA FOR PROTECTORS: PROTECTOR HOUSING WERE MANUFACTURED BY NOLATO SUPPLIER. CURRENTLY, THEY ARE MOLDED IN BD SAN AGUSTIN PLANT. VISUAL INSPECTIONS AND CRITICAL DIMENSIONS FOR PROTECTOR HOUSING PARTS ARE PERFORMED ACCORDING TO PH-300 CURRENT VERSION. DURING ASSEMBLY PROCESS, THE OPERATOR PERFORMS THE FOLLOWING INSPECTIONS AND TESTS ACCORDING TO PH-302 CURRENT VERSION: -IT IS VERIFIED THAT EXPANSION FILM OF THE BLADDER IS CENTERED IN THE PROTECTOR HOUSING, CORRECTLY SEALED AND FREE OF HOLES OR DAMAGES. -VISUAL INSPECTION OF THE FILTER IS PERFORMED TO VERIFY THAT IS CENTERED IN THE PROTECTOR CAVITY, WELDED IN A RIGHT POSITION AND FREE OF HOLES BETWEEN THE FILTER AND FILTER COVER. -OVERPRESSURE TEST IS PERFORMED TO VERIFY THAT THE EXPANSION FILM OF THE BLADDER CAN RESIST CERTAIN PRESSURE. -FILM BREAKAGE TEST: THE EXPANSION FILM OF THE BLADDER MUST BREAK AT MINIMUM PRESSURE (0,8 BAR). IT IS VERIFY IF THE BREAK IS PRODUCED IN THE SEALING AREA OR AT THE FILM. -FUNCTIONALITY TEST IS PERFORMED TO ENSURE PROPERLY WORK OF THE PROTECTOR. - HYDROPHOBIC FILTER LEAKAGE IS PERFORMED TO VERIFY THAT NO LEAKS ARE PRESENT IN THE FILTER. THE LEAK WAS CONFIRMED, HOWEVER, AFTER RECONNECTION NO LEAK WAS FOUND. THAT MEANS THAT THE PROTECTOR WORK PROPERLY BUT AT FIRST TIME, IT WAS NOT PROPERLY ATTACHED TO THE VIAL. IT IS RECOMMENDED TO FOLLOW THE INSTRUCTIONS EXPLAINED IN THE IFU. ASSEMBLY FIXTURE MAKES EASIER THE CONNECTION

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LEAKAGE OCCURRED BETWEEN THE BD PHASEAL¿ PROTECTOR P15J AND VIAL. THIS OCCURRED ON 3 SEPARATE OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN.

    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 LEAKAGE OCCURRED BETWEEN THE BD PHASEAL¿ PROTECTOR P15J AND VIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1043445 BD PHASEAL¿ PROTECTOR P15J PHASEAL ADMINISTRATION SET LHI BECTON DICKINSON, S.A. 1704120

    Patients

    Seq Age Sex Outcome Treatment
    1 Other