BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM

    MDR report key: 6103376 · Received November 15, 2016

    Report

    Report Number
    3006425876-2016-00359
    Event Type
    Malfunction
    Date Received
    November 15, 2016
    Date of Event
    October 25, 2016
    Report Date
    October 25, 2016
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    LFJ
    PMA / PMN Number
    K895417
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    QN#(B)(4). THIS REPORT IS FOR THE FIRST IN A SERIES OF THREE CONSECUTIVE PRODUCT PROBLEMS WITH THE SAME PATIENT. THE SECOND AND THIRD ISSUES HAVE BEEN REPORTED UNDER MDR # 3006425876-2016-00358 AND 3006425876-2016-00360.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE REPORT THAT THE GUIDE WIRE AND DILATOR WERE BENT WAS CONFIRMED. RETURNED WERE A GUIDE WIRE AND A DILATOR. THE DILATOR BODY WAS SLIGHTLY BENT AT THE DISTAL END. UNDER MICROSCOPIC EXAMINATION, THE DISTAL TIP OF THE DILATOR WAS SLIGHTLY FOLDED BACK ON BOTH SIDES. THERE WERE WHITE REGIONS IN THE TIP, INDICATING THAT IT HAD BEEN EXPOSED TO STRESS. THE GUIDE WIRE WAS BENT INTO A U SHAPE FROM THE DISTAL END UNTIL THE 20 CM MARK. THERE WAS A KINK IN THE WIRE 40 CM FROM THE BOTTOM OF THE J-BEND. A MANUAL TUG TEST CONFIRMED THAT BOTH WELDS WERE INTACT. THE LENGTH OF THE GUIDE WIRE MEASURED 68.4 CM. THE LENGTH OF THE GUIDE WIRE WAS CONSISTENT WITH THE GUIDE WIRE GRAPHIC. THE OUTSIDE DIAMETER (OD) OF THE GUIDE WIRE MEASURED 0.856 MM, WHICH MET SPECIFICATION OF 0.838 - 0.877 MM PER THE GUIDE WIRE GRAPHIC. THE INSIDE DIAMETER (ID) OF THE DILATOR TIP MEASURED 0.0365 INCHES, WHICH MET SPECIFICATION OF 0.036 - 0.038 INCHES PER THE GUIDE WIRE GRAPHIC. THE PROXIMAL END OF THE GUIDE WIRE WAS INSERTED INTO THE DISTAL TIP OF THE DILATOR AND THE DILATOR PASSED OVER THE ENTIRE GUIDE WIRE WITH MINIMAL RESISTANCE. THE INSTRUCTION BOOKLET PROVIDED WITH THE KIT DESCRIBES AN INSERTION PROCEDURE INCLUDING THE STEP TO ENLARGE OTHER REMARKS: THE CUTANEOUS PUNCTURE SITE WITH THE CUTTING EDGE OF A SCALPEL PRIOR TO DILATING. THE CUSTOMER DID NOT REPORT WHETHER OR NOT THIS STEP WAS PERFORMED. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED ISSUE. THE DAMAGE TO THE GUIDE WIRE AND DILATOR IS CHARACTERISTIC OF ENCOUNTERING RESISTANCE DURING INSERTION. BASED ON THE CONDITION OF THE SAMPLE AND THE REPORT THAT IT OCCURRED DURING INSERTION, OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO THIS EVENT. NO FURTHER ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENT OCCURRED AT THE RECOVERY ROOM. THE GUIDE WIRE COULD BE INSERTED WITHOUT PROBLEMS. AFTER INSERTION OF THE DILATOR A RESISTANCE WAS FELT, DILATOR COULD NOT BE INSERTED FULLY AND THE GUIDE WIRE HAD TO BE REMOVED TOGETHER WITH THE DILATOR. AFTER REMOVAL, THE GUIDE WIRE WAS UNRAVELED AND BENT AND THE DILATOR WAS FOUND TO BE SLITTED AND ALSO BENT. AS A RESULT A SECOND ATTEMPT WAS PERFORMED WITHOUT SUCCESS SINCE THE SAME ISSUE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753039 HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM ACUTE HEMODIALYSIS CATHETER PRODUCTS LFJ ARROW INTERNATIONAL INC. 71F16E0911

    Patients

    Seq Age Sex Outcome Treatment
    1