BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ PROTECTOR SOLUS P120J

    MDR report key: 8232987 · Received January 10, 2019

    Report

    Report Number
    3003152976-2018-00584
    Event Type
    Malfunction
    Date Received
    January 10, 2019
    Date of Event
    December 19, 2018
    Report Date
    February 6, 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

    INVESTIGATION SUMMARY: DHR: N/A - NO LOT. TWO SAMPLE UNITS WERE RECEIVED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THE SAMPLES WERE EVALUATED BY JFR LAB. ACCORDING TO THE REPORT: NO FMS WERE FOUND NEITHER INSIDE VIAL NOR INFUSION BAG. NO DEFECT WAS FOUND IN THE MEMBRANES. PHASEAL NEEDLES ARE DESIGNED TO REDUCE THE CORING TENDENCY. IF CORING COMES FROM MEMBRANE: A)HUMAN ERROR: PERFORMING MULTIPLE INJECTIONS ON THE MEMBRANE COULD LEAD TO FRAGMENTATION. B)MACHINES: IF MEMBRANE IS EXCESSIVELY WELDED, CONSISTENCY IS HIGHER AND ELASTICITY LOWER, AND ONCE IT IS PIERCED BY THE NEEDLE, IT COULD PROVOKE MEMBRANE FRAGMENTATION. C)MATERIALS: NEEDLES. SEE BELOW. IF CORING COMES FROM RUBBER STOPPER: D)MATERIALS: RUBBER STOPPER. QUALITY OF RUBBER STOPPER WILL IMPACT THE OCCURRENCE OF PARTICLES. THE LARGER THE PERCENTAGE OF INORGANIC FILLER IN THE RUBBER STOPPER, THE MORE OFTEN CORES AND FRAGMENTS WILL BE PRODUCED. CAPPING CONDITIONS HAVE SHOWN TO HAVE SIGNIFICANT EFFECT ON CORING TENDENCY. THE TYPE OF CRIMPING DEVICE USED AS WELL AS THE SEALING FORCE WILL HAVE AN INFLUENCE ON CORING. E)MATERIALS: NEEDLES. DESIGN AND DIMENSIONS OF THE NEEDLE INFLUENCE THE TENDENCY FOR CORING, ESPECIALLY REGARDING THE PRODUCTION OF LARGER CORES, CUT OUT FROM THE RUBBER STOPPER BY THE NEEDLE EDGES. PHASEAL NEEDLES ARE DESIGNED TO REDUCE OCCURRENCE OF CORING. F)MISUSE BY THE USER: IF THE USER MAKES A BAD CONNECTION OR TURN THE PROTECTOR ON THE CAP OF THE VIAL RATHER THAN INSERT IT VERTICALLY, THE CANNULA OF THE PROTECTOR BECAUSE OF THE RUBBING WITH THE STOPPER OF THE VIAL MAY CAUSE DETACHMENT OF PARTICLES FROM THE CAP OF THE VIAL. IT IS RECOMMENDED TO CAREFULLY FOLLOW THE INSTRUCTIONS EXPLAINED IN THE IFU. FOR EVERY MANUFACTURED LOT THE LABORATORY TECHNICIAN MADE THE PARTICLES FRAGMENTATION TEST ACCORDING TO THE IT-1730 PROCEDURE. THE TEST IS CARRIED OUT WITHIN A IN A LAMINATE FLOW HOOD. STAFF HAS TO WEAR A LAB COAT, CAP AND GLOVES. IN THIS CASE, THE COMPLAINT WAS NOT CONFIRMED. THE ROOT CAUSE CANNOT BE ESTABLISHED. PRIOR TO THE INVESTIGATION OF THIS COMPLAINT, A CAPA (688697) WAS OPEN TO ASSESS THE CORING DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD PHASEAL¿ PROTECTOR SOLUS P120J THERE WAS AN ISSUE WITH GREY FRAGMENTS FROM RUBBER STOPPER WERE FOUND IN THE INFUSION BAG AND VIAL.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED WITH THE USE OF THE BD PHASEAL¿ PROTECTOR SOLUS P120J, THERE WAS AN ISSUE WITH GREY FRAGMENTS FROM RUBBER STOPPER WERE FOUND IN THE INFUSION BAG AND VIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26947 BD PHASEAL¿ PROTECTOR SOLUS P120J PHASEAL ADMINISTRATION SET LHI BECTON DICKINSON, S.A. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other