BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE STEP MULTI-DRUG ORAL FLUID TEST CUBE

    MDR report key: 7640813 · Received June 27, 2018

    Report

    Report Number
    3004635103-2018-52502
    Event Type
    Malfunction
    Date Received
    June 27, 2018
    Date of Event
    May 16, 2018
    Report Date
    May 22, 2020
    Manufacturer
    GUANGZHOU WONDFO BIOTECH CO., LTD.
    Product Code
    PVD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    ON MAY 16TH, 2018, OUR US CLIENT ALERE RANDOMLY SELECTED OUR PRODUCT ONE STEP MULTI-DRUG ORAL FLUID TEST CUBE (LOT NO.W61080201,W61080202,W60680202) FOR INSPECTION. FIFTEEN SALIVA SPONGE COLLECTORS (ACCESSORIES OF THE TEST CUBE) WERE SELECTED AND IT WAS FOUND THAT 5 OF THE 15 FOAM TIPS HAD FALLEN OFF. THIS PRODUCT MEET THE INTERNAL SPECIFICATIONS, IS USED FOR DIAGNOSIS AND THE FAILURE OF THE ACCESSORY MAY LEAD TO A MDR REPORTABLE EVENTS. THE POTENTIAL FAILURE OF THE SPONGE COLLECTOR MAY LEAD TO THE FOLLOWING CONSEQUENCES: (1) AFFECTING THE USE OF THE PRODUCT; (2) CAUSING RISKS OF EATING BECAUSE THE FOAM TIP MAY BE DISLODGED IN THE USER'S MOUTH. WE HAVE CONDUCTED AN INVESTIGATION AND THE CAUSES OF THE FAILURE ARE IDENTIFIED AS FOLLOWS: (1) FOR STRUCTURAL DESIGN: THE OUTER SURFACE OF THE FOAM TIP IS NOT FIXED, AND IT IS ONLY AFFIXED BY HOT-MELT ADHESIVE ON THE END FACE, WHICH MAKES IT EASY TO FALL OFF. (2) FOR PROCESS FLOW: A) ACCORDING TO THE EXISTING PRODUCT TECHNOLOGY, HOT-MELT ADHESIVES MUST BE SPOTTED TO THE PLASTIC PARTS FIRST, AND THEN THE SPONGES WILL BE ASSEMBLED. THE PROCESS CANNOT BE CONTROLLED DUE TO MANUAL OPERATIONS, WHICH MAY CAUSE THE HOTMELT ADHESIVES TO CURE IN ADVANCE AND THE ADHESION IS NOT GOOD. B) NO KEY PARAMETERS FOR THIS PROCESS, ONLY RELYING ON THE VISUAL INSPECTION AND CONTROL OF EMPLOYEES, AND THE LACK OF STANDARDS FOR THE AMOUNT OF GLUE LEADS TO UNEVEN COATING. (3) QUALITY CONTROL: NO CONTROLLED SOP FOR THIS PROCESS. THERE IS ONLY ONE INTERNAL OPERATION GUIDELINE, WHICH CANNOT ENSURE THE OPERATORS PERFORM ACCORDING TO THE GUIDELINES. QUALITY SUPERVISION IS MISSING. CORRECTIVE OR REMOVAL ACTIONS: (1) ASK OUR CLIENT TO RETURN THE PRODUCTS TO WONDFO, AND THE PRODUCTS WILL BE PUT IN THE DESIGNATED AREA AND ISLOATED. THE INVOLVED BATCHES THAT THE ACCESSORY FAILURE MAY EXIST IN ARE: W61071201, W61071202, W60680201, W60680202, W60880201, W61080201, W61080202, W60980201, W61080402, W60680401 (ESTIMATED COMPLETION TIME: 2018-6-15). (2) REASSESS THE RATIONALITY OF THE EXISTING PRODUCTION PROCESSES AND THE EFFECTIVENESS OF THE EXISTING QUALITY CONTROL (ESTIMATED COMPLETION TIME: 2018-6-30). (3) REVISE THE RELEVANT SOP AND RETRAIN THE RELEVANT PERSONNEL. ONLY THE PERSONNEL WHO PASS THE EXAM CAN TAKE UP POSTS (ESTIMATED COMPLETION TIME: 2018-6-30). (4) REPLACE THE PRODUCTS FOR THE CUSTOMERS (ESTIMATED COMPLETION TIME: WITHIN ONE MONTH AFTER THE PRODUCTS ARE RETURNED). COMPLETION OF CORRECTIVE OR REMOVAL ACTIONS: (1) THE RECALL STATEMENT WAS ISSUED ON MAY 18TH, 2018, ASKING THE END USERS TO RETURN THE PRODUCT TO ABBOTT. BY OCTOBER 17, 2019, A TOTAL NUMBER OF 394,460 PRODUCTS HAVE BEEN RECALLED. (2) ON JUNE 12TH, 2018, THE RATIONALITY OF THE EXISTING PRODUCTION PROCESSES AND THE EFFECTIVENESS OF THE EXISTING QUALITY CONTROL WAS EVALUATED.THE WHOLE PROCEDURES OF SALIVA SPONGE COLLECTORS WERE EVALUATED, AND THE PRODUCT QUALITY CONTROL WAS EFFECTIVE. (3) ON JUNE 9TH, 2018, THE POSITION OF THE SALIVA COLLECTOR WAS CHANGED, AND THE SPOT POSITION OF THE HOT-MELT ADHESIVE WAS CHANGED FROM THE SAMPLING ROD TO THE SAMPLING PAD. SOP-PM-108 "STANDARD OPERATING PROCEDURES FOR SALIVER COLLECTOR" WAS CONTROLLED, AND HAVE CONDUCTED TRAINING FOR RELEVANT STAFFS. (4) FROM AUGUST TO NOVEMBER 2018, THE FIRST ROUND OF REWORK ON THE RECALLED PRODUCTS WAS CARRIED OUT WITH A TOTAL NUMBER OF 157,400T, AND 157,080T HAS BEEN RETURNED TO THE CUSTOMER. IN FEBRUARY 2019, THE CUSTOMER REFUSED TO ACCEPT THE REMAINING REWORKED PRODUCTS. THEREFORE, FROM APRIL TO MAY 2019, THE SECOND ROUND OF REWORK WAS CARRIED OUT WITH A TOTAL NUMBER OF 55,400T, AND THEY WERE REWORKED INTO FUO PRODUCTS AND CONVERTED INTO WONDFO NORMAL PRODUCTS. LATER, THE REMAINING PRODUCTS WITH A NUMBER OF 181,660T WILL BE SCRAPPED.

    Additional Manufacturer Narrative · 1

    WE HAVE STARTED TO REPORT THIS ADVERSE EVENT SINCE 5.25. HOWEVER, DUE TO SOME POSSIBLE TECHNICAL PROBLEMS, WE HAVE NOT SUCCESSFULLY SUBMITTED THE DOCUMENTS. THEREFORE, WE CONSULTED WITH FDA OFFICIALS AND MAINTAINED CLOSE COMMUNICATION TO SOLVE THE PROBLEM. FDA OFFICIALS HAVE SUGGESTED THAT WE CAN ADDRESS THE REASONS FOR NOT BEING ABLE TO REPORT IN A TIMELY MANNER IN THIS SECTION.

    Description of Event or Problem · 1

    ON (B)(6) 2018, OUR US CLIENT ALERE RANDOMLY SELECTED OUR PRODUCT ONE STEP MULTI-DRUG ORAL FLUID TEST CUBE (LOT NO. W61080201,W61080202,W60680202) FOR INSPECTION. FIFTEEN SALIVA SPONGE COLLECTORS (ACCESSORIES OF THE TEST CUBE) WERE SELECTED AND IT WAS FOUND THAT 5 OF THE 15 FOAM TIPS HAD FALLEN OFF. THIS PRODUCT MEET THE INTERNAL SPECIFICATIONS, IS USED FOR DIAGNOSIS AND THE FAILURE OF THE ACCESSORY MAY LEAD TO A MDR REPORTABLE EVENTS. THE POTENTIAL FAILURE OF THE SPONGE COLLECTOR MAY LEAD TO THE FOLLOWING CONSEQUENCES: (1) AFFECTING THE USE OF THE PRODUCT; (2) CAUSING RISKS OF EATING BECAUSE THE FOAM TIP MAY BE DISLODGED IN THE USER'S MOUTH. WE HAVE CONDUCTED AN INVESTIGATION AND THE CAUSES OF THE FAILURE ARE IDENTIFIED AS FOLLOWS: (1) FOR STRUCTURAL DESIGN: THE OUTER SURFACE OF THE FOAM TIP IS NOT FIXED, AND IT IS ONLY AFFIXED BY HOT-MELT ADHESIVE ON THE END FACE, WHICH MAKES IT EASY TO FALL OFF. (2) FOR PROCESS FLOW: A) ACCORDING TO THE EXISTING PRODUCT TECHNOLOGY, HOT-MELT ADHESIVES MUST BE SPOTTED TO THE PLASTIC PARTS FIRST, AND THEN THE SPONGES WILL BE ASSEMBLED. THE PROCESS CANNOT BE CONTROLLED DUE TO MANUAL OPERATIONS, WHICH MAY CAUSE THE HOTMELT ADHESIVES TO CURE IN ADVANCE AND THE ADHESION IS NOT GOOD. B) NO KEY PARAMETERS FOR THIS PROCESS, ONLY RELYING ON THE VISUAL INSPECTION AND CONTROL OF EMPLOYEES, AND THE LACK OF STANDARDS FOR THE AMOUNT OF GLUE LEADS TO UNEVEN COATING. (3) QUALITY CONTROL: NO CONTROLLED SOP FOR THIS PROCESS. THERE IS ONLY ONE INTERNAL OPERATION GUIDELINE, WHICH CANNOT ENSURE THE OPERATORS PERFORM ACCORDING TO THE GUIDELINES. QUALITY SUPERVISION IS MISSING. CORRECTIVE OR REMOVAL ACTIONS: (1) ASK OUR CLIENT TO RETURN THE PRODUCTS TO WONDFO, AND THE PRODUCTS WILL BE PUT IN THE DESIGNATED AREA AND ISOLATED. THE INVOLVED BATCHES THAT THE ACCESSORY FAILURE MAY EXIST IN ARE: W61071201, W61071202, W60680201, W60680202, W60880201, W61080201, W61080202, W60980201, W61080402, W60680401 (ESTIMATED COMPLETION TIME: 2018-6-15). (2) REASSESS THE RATIONALITY OF THE EXISTING PRODUCTION PROCESSES AND THE EFFECTIVENESS OF THE EXISTING QUALITY CONTROL (ESTIMATED COMPLETION TIME: 2018-6-30). (3) REVISE THE RELEVANT SOP AND RETRAIN THE RELEVANT PERSONNEL. ONLY THE PERSONNEL WHO PASS THE EXAM CAN TAKE UP POSTS (ESTIMATED COMPLETION TIME: 2018-6-30). (4) REPLACE THE PRODUCTS FOR THE CUSTOMERS (ESTIMATED COMPLETION TIME: WITHIN ONE MONTH AFTER THE PRODUCTS ARE RETURNED). TO DATE, THERE HAVE BEEN NO REPORTED INSTANCES OF DEATH OR INJURY ASSOCIATED WITH THIS PRODUCT FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486675 ONE STEP MULTI-DRUG ORAL FLUID TEST CUBE ONE STEP MULTI-DRUG ORAL FLUID TEST CUBE PVD GUANGZHOU WONDFO BIOTECH CO., LTD. W61071201

    Patients

    Seq Age Sex Outcome Treatment
    1