BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL PROTECTOR P50J

    MDR report key: 12019461 · Received June 17, 2021

    Report

    Report Number
    3003152976-2021-00329
    Event Type
    Malfunction
    Date Received
    June 17, 2021
    Date of Event
    March 26, 2021
    Report Date
    June 14, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: DHR FROM LOT 2005128 (ASSEMBLY LOTS 0133780 AND 0135928) WERE REVIEWED NOT FINDING ANY NONCONFORMANCE OR DEVIATION THAT COULD BE RELATED TO THE EVENT REPORTED. HOWEVER; ONE MAINTENANCE ORDER (B)(4) WAS RECORDED DURING THE ASSEMBLY PROCESS FROM LOT 0133780, DUE TO A MECHANICAL WEAR OF THE TWEEZERS FROM THE STATION NUMBER 20 (CAVITY ONE) IN CHARGE OF THE TRANSFER OF THE CANNULA BEFORE BEING INSERTED INTO THE PROTECTOR HOUSING. THE TWEEZERS WERE REPLACED AND THE INCIDENT WAS SOLVED. NO QUALITY INCIDENTS WERE RECORDED AFTER THE MAINTENANCE INTERVENTION. AFTER A VISUAL INSPECTION OF SAMPLE RECEIVED BY THE CUSTOMER; IT IS NOTICED THAT THE PROTECTOR WAS ASSEMBLED IN CAVITY 2 FROM THE ASSEMBLY MACHINE P3. THEREFORE; THE WORK ORDER SEEMS TO BE NOT RELATED TO THE EVENT REPORTED AS THE CAVITY INVOLVED IN THE FAILURE RECORDED WAS CAVITY NUMBER ONE FROM ASSEMBLY MACHINE P3. THEREFORE; NO INCIDENTS OCCURRED DURING THE PROCESS THAT COULD BE RELATED TO THE EVENT REPORTED. ONE PROTECTOR P50J FROM LOT 2005128 FROM ASSEMBLY MACHINE P3 (CAVITY TWO) WAS RECEIVED BY THE CUSTOMER. THE SAMPLE WAS RECEIVED OUTSIDE THE ORIGINAL UNITARY PACKAGING LEADING TO STATE THAT THE SAMPLE WAS ALREADY USED. AFTER REMOVING THE GREEN CAP FROM THE PROTECTOR SAMPLE RECEIVED BY THE CUSTOMER, IT IS NOTICED THAT THE CANNULA FROM THE PROTECTOR WAS DETACHED FROM THE NEEDLE HOUSING. IF THE NEEDLE HOUSING FROM THE PROTECTOR IS OBSERVED, A DAMAGE CAN BE NOTICED. IT SEEMS THAT MAY BE THE CANNULA WAS BENT DAMAGING THE NEEDLE HOUSING. THE CANNULA WAS ALSO OBSERVED UNDER MICROSCOPE(X3) AND NICKS WERE OBSERVED ON THE TOP, LEADING TO STATE THAT MAY IT WOULD NOT BE PROPERLY CONNECTED TO THE VIAL. SINCE THE EVENT REPORTED OCCURRED AFTER THE CONNECTION PERFORMED BY THE USER AND BASED ON SAMPLE RECEIVED, IT SEEMS THAT MOST PROBABLY THE CANNULA PUNCTURED INCLINED THE VIAL, BEING BENT DURING THE CONNECTION, DAMAGING THE NEEDLE HOUSING AND BEING FINALLY DETACHED FROM THE PROTECTOR HOUSING. RETAINED SAMPLES ASSESSMENT: FIVE RETAINED PROTECTORS P50J FROM LOT 2005128 WERE REQUESTED FOR THE INVESTIGATION. AFTER A VISUAL INSPECTION OF ALL PROTECTORS REQUESTED , NO ISSUES WERE FOUND. NO NEEDLE BENT OR DETACHED FROM THE PROTECTOR COULD BE OBSERVED IN ANY OF RETAINED SAMPLES RECEIVED. INSPECTIONS AND TEST PERFORMED: DURING MOLDING PROCESS, HOUSING IS REVIEWED ACCORDING TO PH-300 (CURRENT VERSION). IT IS VERIFIED THE ABSENCE OF BURS, DIRTY AND THE PROPERLY MEASURES OF THE NEEDLE HOUSING (PASS/FAIL). DURING ASSEMBLY PROCESS, THE OPERATOR PERFORMS THE VISUAL INSPECTION OF THE PROTECTOR ACCORDING TO PH-302 (CURRENT VERSION). THE CANNULA IS CHECKED: IT IS VERIFIED THAT IS PROPERLY CENTERED, ORIENTED AND PROPERLY ASSEMBLED. IT IS ALSO VERIFIED THAT IT HAS NOT ANY TYPE OF DAMAGE (NICKS). DURING ALL THE TESTS PERFORMED ACCORDING TO PH-302 (OVERPRESSURE TEST, LEAKAGE TEST, ETC) THE ABSENCE/ FALL OF THE CANNULA WOULD BE NOTICED. ALSO IF THE CANNULA WOULD BE BENT. THE ASSEMBLY MACHINE (P3) HAS SEVERAL AUTOMATIC CONTROLS WHICH CHECK THE PRESENCE (STATION 21), LENGTH (STATION 22) AND PROPERLY POSITION (STATION 23) OF THE CANNULA. IF ONE OF THE STATIONS DETECTS ANY PROBLEM RELATED TO THE CANNULA (ABSENCE, INCORRECT LENGTH, WRONG POSITION-CANNULA BENT), THE PIECE IS THROWN AWAY (SCRAP) AND DO NOT CONTINUE THE NORMAL PROCESS. TEST PERFORMED ON THE ASSEMBLY PROTECTOR MACHINE P3: PROTECTOR SAMPLE P50J RECEIVED (WITHOUT CANNULA) WAS PLACED IN THE STATIONS 21, 22 AND 23 TO CHALLENGE AUTOMATIC CONTROLS FROM THE ASSEMBLY MACHINE. THE AUTOMATIC CONTROLS MARKED THE SAMPLE AS BAS PRODUCT AND THE PRODUCT WAS THROWN AWAY (SCRAP). MOREOVER; TESTING WAS REPEATED USING AN ADDITIONAL PROTECTOR P50J SAMPLE WITH THE NEEDLE BENT. THE PRODUCT WAS MARKED AS BAD PRODUCT BY THE AUTOMATIC CONTROLS FORM THE ASSEMBLY MACHINE AND WAS THROWN AWAY (SCRAP). THEREFORE; THE EVENT REPORTED COULD NOT BE REPLICATED DURING THE INVESTIGATION. SINCE NO ISSUES WERE FOUND DURING DHR THAT COULD BE RELATED TO THE EVENT REPORTED, NO ISSUES WERE FOUND DURING LOT RELEASE TESTING AND CONSIDERING THAT THE DEFECT WAS FOUND AFTER THE CONNECTION PERFORMED BY THE USER AND THE ASSEMBLY MACHINE P3 HAS SEVERAL AUTOMATIC CONTROLS WHICH CHECK THE PRESENCE, LENGTH AND POSITION THAT WOULD DETECTED THE EVENT REPORTED; THE MOST LIKELY ROOT CAUSE WOULD BE A MISUSE OF THE DEVICE BY THE USER. BASED ON THE DAMAGE ON THE CANNULA AND NEEDLE HOUSING FROM PROTECTOR SAMPLE RECEIVED IT SEEMS THAT MOST PROBABLY THE CANNULA PUNCTURED INCLINED THE VIAL, BEING BENT DURING THE CONNECTION, DAMAGING THE NEEDLE HOUSING AND BEING FINALLY DETACHED FROM THE PROTECTOR HOUSING. SINCE ROOT CAUSE CANNOT BE CLEARLY ESTABLISHED AND THE EVENT REPORTED COULD NOT BE REPLICATED DURING THE INVESTIGATION, NO ACTION ARE NEEDED AT THIS MOMENT. COMPLAINT WILL BE TRACKED FOR TRENDS VIA QDA METRICS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AIR VENT NEEDLE CONNECTED TO THE BD PHASEAL¿ PROTECTOR P50J HAD PARTIALLY SEPARATED DUE TO BEING ASSEMBLED "DIAGONALLY". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "ACCORDING TO THE CUSTOMER'S REPORT, THE HCP ATTEMPTED TO ATTACH THE PROTECTOR TO A VIAL BUT COULD NOT DO IT PROPERLY. WHEN CHECKING THE PROTECTOR, THE AIR VENT NEEDLE WAS FOUND TO HAVE BEEN PLACED/ASSEMBLED DIAGONALLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913065 BD PHASEAL PROTECTOR P50J INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 2005128

    Patients

    Seq Age Sex Outcome Treatment
    1