BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL ADMINISTRATION PRODUCTS - IV BAG ACCESS

    MDR report key: 11766657 · Received May 3, 2021

    Report

    Report Number
    9616066-2021-50871
    Event Type
    Malfunction
    Date Received
    May 3, 2021
    Date of Event
    April 5, 2021
    Report Date
    June 16, 2021
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY : THE OFFENDING DEVICE WAS UNFORTUNATELY NOT AVAILABLE. INSTEAD, WE RECEIVED TWO PHOTOS. ONE OF THE PHOTOS SHOWED THE PAPER-SIDE OF A PACKAGING (FROM LOT M79994-1) AND THE OTHER PHOTO OF A SEEMINGLY UNUSED CYTO-AD Z® INLINE/4 SET. ONE OF THE UPPER Y-SITE ADAPTERS WAS CIRCLED IN ORDER TO MARK THE LEAKY AREA. THE NATURE OF THE LEAK WAS NOT DESCRIBED. WITHOUT THE OPPORTUNITY TO INSPECT THE ORIGINAL SAMPLE, THE CAUSE OF THE LEAK CANNOT BE DEFINITIVELY DETERMINED. IN PRINCIPLE, THE LL-CONNECTION BETWEEN THE CYTO-AD Z® INLINE/4 SET AND A SECONDARY SET CAN LEAK DUE TO MATERIAL FAULTS OR HANDLING ERRORS. MATERIAL FAULTS, SUCH AS BRITTLE WELD- OR KNIT-LINES CAN LEAD TO CRACKS, EVEN IF THESE ADAPTERS ARE NOT EXPOSED TO CRITICAL STRESS. HANDLING ERRORS CAN LEAD TO LEAKAGES, WHEN THE MALE LUER LOCK (MLL) ADAPTERS OF THE SECONDARY DEVICE IS INCORRECTLY SCREWED ON WITH A LITTLE ANGLE (CANTED) OR WHEN THIS MLL ADAPTER IS SCREWED TOO TIGHTLY, THEREBY OVERLOADING THE STABILITY OF THE FLL ADAPTER. A RISK LIKE THIS DEPENDS ON THE DESIGN OF THE LLM ADAPTER, FOR INSTANCE IF ITS ENLARGED OUTER DIAMETER ENABLES GREATER LEVER-FORCES TO BE APPLIED. FINALLY, USING AN ALCOHOLIC-BASED DISINFECTANT CAN MAKE PLASTIC MATERIALS PRONE TO CRACKING AS LONG AS THEY ARE MOIST, EVEN IF THEY ARE NOT SUBJECTED TO CRITICAL STRESS. AFTER DRYING THE MATERIAL IS ENTIRELY STABLE AGAIN. THE COMPLAINT IS UNFOUNDED BECAUSE THE CAUSE OF THE LEAK COULD NOT BE DETERMINED WITHOUT THE POSSIBILITY OF EXAMINING THE OFFENDING SAMPLE. THERE IS NO EVIDENCE THAT MATERIAL OR MANUFACTURING FAULTS WERE CAUSING THE LEAK. IT CAN BE ASSUMED THAT INCORRECT HANDLING OR UNFAVORABLE CONDITIONS WERE THE MOST PROBABLE ROOT CAUSE. THE ACTUAL ROOT CAUSE WAS UNCONFIRMED. THE ISSUE WILL CONTINUE TO BE TRACKED AND MONITORED BY BD. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHASEAL¿ ADMINISTRATION PRODUCTS - IV BAG ACCESS EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING ADMINISTRATION OF CHEMO, THE NURSES ATTACHED THE SECONDARY SET TO TO 1 PORT OF THE C110. WHEN THE PUMP RUNS, CHEMO IS LEAKING FROM THE CONNECTOR THAT IS CONNECTED TO THE Y SITE TUBING.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 THE BD PHASEAL¿ ADMINISTRATION PRODUCTS - IV BAG ACCESS EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING ADMINISTRATION OF CHEMO, THE NURSES ATTACHED THE SECONDARY SET TO TO 1 PORT OF THE C110. WHEN THE PUMP RUNS, CHEMO IS LEAKING FROM THE CONNECTOR THAT IS CONNECTED TO THE Y SITE TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662143 BD PHASEAL ADMINISTRATION PRODUCTS - IV BAG ACCESS INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. M79994-1

    Patients

    Seq Age Sex Outcome Treatment
    1