BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1710034-2018-00691

    MDR report key: 7949845 · Received October 9, 2018

    Report

    Report Number
    1710034-2018-00691
    Event Type
    Malfunction
    Date Received
    October 9, 2018
    Date of Event
    August 31, 2018
    Report Date
    December 17, 2018
    PMA / PMN Number
    K161777
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: DHR- A TOTAL OF (B)(4) WERE MANUFACTURED ON NEXIVA LINE 1 STARTING ON 2FEB18 THROUGH 10FEB18. FOUND 4 NON-RELATED QN¿S: (B)(4) (DAMAGED SEPTUM), (B)(4) (WRONG TIPPING DIE), (B)(4) (RUNNING UNDER RISK-NIKON DOWN), (B)(4) (INCOMPLETE SEAL). ALL OTHER CHALLENGE, SET-UP AND IN PROCESS SAMPLES WERE PERFORMED PER SPECIFICATIONS AND ALL PASSED PER SPECIFICATIONS. RECEIVED A 20GA CATHETER-ADAPTER EXTENSION SET ALONG WITH A PIECE OF TOP WEB (PACKAGING) FROM LOT NUMBER 8031857. VISUAL EVALUATION: TRACES OF PATIENT RESIDUE (BLOOD) WAS VISIBLE THROUGHOUT THE COMPONENTS OF THE UNIT. THE UNIT REVEALED THE END OF THE EXTENSION TUBE WAS NO CORRECTLY INSERTED INTO THE WINGED ADAPTER AND WAS INSTEAD GLUED TO THE TOP PART OF THE PORT. TRACES OF CLEAR ADHESIVE WAS OBSERVED ON THE TUBING AND IN BETWEEN THE PORT AND THE TUBING. CONCLUSION(S): THE EXTENSION TUBING WAS NOT PROPERLY INSERTED INTO THE WINGED ADAPTER, THIS CONDITION WOULD CAUSE THE DEFECT/FAILURE THE CUSTOMER INDICATED. ROOT CAUSE: THIS DEFECT OCCURS DURING THE MANUFACTURING PROCESS ON ZONE 8 AT THE ADHESIVE DISPENSE STATION IF THE CATHETER ADAPTER IS MISALIGNED DURING THE INSERTION OF THE EXTENSION TUBE. CURRENT PROCESS CONTROLS INCLUDE ROUTINE LEAK TESTING AFTER ZONE 9 AS WELL AS A 100% ONLINE FLOW TESTER IN ZONE 8.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BLOOD WAS COMING OUT OF THE PATIENT AND NOT FILLING THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM WITH DUAL PORT . THERE WAS NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    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 BLOOD WAS COMING OUT OF THE PATIENT AND NOT FILLING THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM WITH DUAL PORT . THERE WAS NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION.

    Patients

    Seq Age Sex Outcome Treatment
    0 Other