BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 16471103 · Received March 2, 2023

    Report

    Report Number
    9611102-2023-00014
    Event Type
    Malfunction
    Date Received
    March 2, 2023
    Date of Event
    January 24, 2023
    Report Date
    May 3, 2023
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    GEI
    UDI-DI
    04055207048641
    PMA / PMN Number
    K002000
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    NEW INFORMATION: B4, D9, G1 (CONTACT), G3, G6, H2, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS), AND H10. RICHARD WOLF GMBH HAS NOT RECEIVED THE REPORTED DEVICE FOR INVESTIGATION. THE ROOT CAUSE CANNOT BE DETERMINED. THE SUCT./IRRIG.TUBE SET SPIKE L 3M 4170956 IS USED IN CONJUNCTION WITH SUCTION AND IRRIGATION HANDLE 8385.901 AND SUITABLE IRRIGATION CONTAINERS, PUMPS AS WELL AS FLUID TRAPS OR SECRETION CONTAINERS. A PROBABLE ROOT CAUSE COULD BE A TOO HIGH SELECTED PRESSURE AT THE PUMP PRESSURE WHICH DAMAGES THE SUCT./IRRIG.TUBE SET SPIKE L 3M 4170956. IF THE PRESSURE IS SELECTED TOO HIGH, IT CAUSES LEAKAGE WITHIN THE SUCTION-PURGE SYSTEM OR PINCH VALVES. THE SUCT./IRRIG.TUBE SET SPIKE L 3M 4170956, BATCH 32224432 WAS MANUFACTURED ON 02/JUN/2022. THE BATCH CONSISTED OF 573 PAK OF SUCT./IRRIG.TUBE SET SPIKE L 3M. ONE PAK CONSISTS 10 PIECES OF THE DEVICE. NO ISSUE WAS IDENTIFIED DURING PRODUCTION. IN THE REVIEW PERIOD BETWEEN 01/JAN/2020 AND 06/FEB/2023, 4 SIMILAR COMPLAINTS WERE REPORTED. IN 2 COMPLAINTS, THE REPORTED ISSUE COULD NOT BE CONFIRMED. IN 2 COMPLAINTS, THE ROOT CAUSE WAS IDENTIFIED AS USER ERROR DUE TO TOO HIGH SELECTED PRESSURE AT THE PUMP PRESSURE WHICH DAMAGED THE SUCT./IRRIG.TUBE SET SPIKE L 3M 4170956. THE IFU GA-B145 / EN / 2021-03 V8.0 / PK20-0269 / FOR THE SYSTEM CONTAINS SEVERAL SAFETY INSTRUCTIONS AND NOTES ABOUT THE LIMITED STRENGTH OF THE DEVICE AS WELL ABOUT THE MAXIMAL ALLOWED LEVEL OF PRESSURE WITHIN THE SUCTION-PURGE SYSTEM IN SECTION 7 USE AND IN SECTION 7.2 GENERAL NOTES AND INSTRUCTIONS FOR USE. ALSO, THERE IS SAFETY NOTES REGARDING THE DEVICE COMBINATION IN SECTION 5 COMBINATIONS. FURTHERMORE, THE USER IS ADVISED ABOUT A VISUAL AND FUNCTIONAL CHECKS OF THE ENTIRE SYSTEM PRIOR A PROCEDURE IN SECTION 8 CHECKS. THE SUBJECT ISSUE OF INCORRECT DEVICE COMBINATION IS PRESENT IN THE RISK MANAGEMENT FILE F1-2: SUCTION AND RINSING TUBES, REV. 03. THE OVERALL PROBABILITY OF OCCURRENCE FOR THIS ISSUE REMAINS AT PREVIOUSLY DEFINED LEVELS AND OVERALL RISK OF THE DEVICE REMAINS IN THE ACCEPTABLE CATEGORY.

    Additional Manufacturer Narrative · 0

    RICHARD WOLF GMBH HAS NOT RECEIVED THE REPORTED DEVICE FOR INVESTIGATION.

    Description of Event or Problem · 0

    A USER FACILITY REPRESENTATIVE REPORTS AN ISSUE REGARDING SUCT./IRRIG.TUBE SET SPIKE L 3M PVC PART NO. 4170956 WITH LOT NO. 32224432. THE REPRESENTATIVE REPORTED THAT THE TUBE FOR SUCTION COLLAPSES AND CANNOT BE FIXED. IT CANNOT SUCTION LARGE AMOUNTS OR THICKER AMOUNTS OF FLUID. THEY WOULD HAVE TO OPEN THE PATIENT UP IN ORDER TO SUCTION PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1825855 NA SUCT./IRRIG.TUBE SET SPIKE L 3M GEI RICHARD WOLF GMBH 4170956 32224432 04055207048641

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other