BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WAYNE PNEUMOTHORAX SET

    MDR report key: 8296744 · Received February 1, 2019

    Report

    Report Number
    1820334-2019-00350
    Event Type
    Malfunction
    Date Received
    February 1, 2019
    Date of Event
    January 7, 2019
    Report Date
    March 21, 2019
    Manufacturer
    COOK INC
    Product Code
    JOL
    UDI-DI
    00827002565333
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION - EVALUATION. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, QUALITY CONTROL AND SPECIFICATIONS OF THE DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, IMAGES WERE PROVIDED BY THE DISTRIBUTION CENTER AND CONFIRMED THE PRESENCE OF FOREIGN MATTER WITHIN THE COMPLAINT DEVICE PACKAGING. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. IT WAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD FOR LOT 9024305 REVEALED THREE NONCONFORMANCES, NONE OF WHICH ARE RELATED TO THE REPORTED FAILURE MODE. THE DRAINAGE BAG TUBE CONNECTOR SUBASSEMBLY LOT (IC8920644) RECORDED ONE NONCONFORMANCE, IN WHICH TWO DEVICES WERE SCRAPPED OUT FOR FOREIGN MATTER AT THE DISTAL END. IT SHOULD BE NOTED THAT NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR THE MAIN OR SUBASSEMBLY LOTS. WORK LOGS FOR PACKAGING QUALITY CONTROL WERE REVIEWED AND NO OTHER LOTS WORKED ON DURING THAT TIME HAVE HAD COMPLAINTS REPORTED FOR FOREIGN MATTER. BASED ON THIS INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THERE IS ANY OTHER NONCONFORMING PRODUCT IN HOUSE OR OUT IN THE FIELD. BASED ON THE INFORMATION PROVIDED, NO RETURNED PRODUCT AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE CAN BE TRACED TO MANUFACTURING. FOREIGN MATTER COULD HAVE CONTAMINATED THE DEVICE AND/OR COMPONENTS DURING THE MANUFACTURING PROCESS AND WERE SUBSEQUENTLY SEALED INSIDE DURING PACKAGING. A QUALITY ENGINEER RISK ASSESSMENT WAS CONDUCTED TO ASSESS THE RISK OF THIS FAILURE MODE AND CONCLUDED NO RISK REDUCTION ACTIVITIES ARE REQUIRED AT THIS TIME. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(6). OCCUPATION: QUALITY TRAINEE. PMA/510(K) #: EXEMPT. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER WAS DISCOVERED INSIDE THE PRIMARY PACKAGE OF A WAYNE PNEUMOTHORAX SET UPON INSPECTION AT THE DISTRIBUTION CENTER. NO PATIENT CONTACT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91056 WAYNE PNEUMOTHORAX SET JOL CATHETER AND TIP, SUCTION JOL COOK INC G56533 9024305 00827002565333

    Patients

    Seq Age Sex Outcome Treatment
    1