BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 19974726 · Received August 13, 2024

    Report

    Report Number
    1820334-2024-01080
    Event Type
    Malfunction
    Date Received
    August 13, 2024
    Report Date
    November 19, 2024
    Manufacturer
    COOK INC
    Product Code
    JOL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    B3 - APPROXIMATELY 45-50 DAYS AGO FROM 30JUL2024. D2A & D2B: THE EXACT IDENTITY OF THE DEVICE IS CURRENTLY UNKNOWN; HOWEVER, THE EVENT OCCURRED DURING THE USE OF A WAYNE PNEUMOTHORAX SET. THEREFORE, PRODUCT CODE JOL HAS BEEN SELECTED. THE PRODUCT CODE WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BE PROVIDED. E1 - (B)(6). E3- OCCUPATION: BUYER. G4 - PMA/510(K) #: THE EXACT IDENTITY OF THE DEVICE IS CURRENTLY UNKNOWN. PMA/510(K)# SECTION WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BE PROVIDED. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED OR UNAVAILABLE. INVESTIGATION ¿ EVALUATION. IT WAS REPORTED THAT THE WIRE GUIDE FROM AN UNKNOWN COOK WAYNE PNEUMOTHORAX SET SEPARATED. THE DEVICE WAS INSERTED BY A PHYSICIAN WITH THE HELP OF ANOTHER DOCTOR IN THE EMERGENCY ROOM (ER). DURING THE PROCEDURE, THE WIRE GUIDE FRACTURED, AND A PIECE OF THE WIRE WAS RETAINED IN THE CHEST TUBE. THE CHEST TUBE AND WIRE WERE REMOVED FROM THE PATIENT, AND NEW CHEST TUBE WAS PLACED TO COMPLETE THE PROCEDURE. THE COMPLAINT DEVICE PACKAGING WAS DISCARDED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. REVIEWS OF THE DOCUMENTATION, INCLUDING THE QUALITY CONTROL PROCEDURES, SPECIFICATIONS AND INSTRUCTIONS FOR USE (IFU) OF THE DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A PHYSICAL EXAMINATION COULD NOT BE CONDUCTED. HOWEVER, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE DHR WAS UNABLE TO BE COMPLETED, DUE TO THE LACK OF LOT INFORMATION FROM THE COMPLAINT FACILITY. COOK ALSO REVIEWED PRODUCT LABELING: THE CURRENT INSTRUCTIONS FOR USE [T_FCWG_REV2] (FIXED CORE WIRE GUIDES) IS SUPPLIED WITH THIS DEVICE. THE PRODUCT IFU STATES THE FOLLOWING IN CONSIDERATION OF THE REPORTED FAILURE MODE: PRECAUTIONS: ¿ DO NOT ADVANCE OR WITHDRAWAL A WIRE GUIDE WHEN RESISTANCE IS ENCOUNTERED, AS PERFORATION COULD OCCUR. ¿ USE ONLY FLEXIBLE END AS THE INITIAL INSERTED END. INSERTING FROM THE RIGID END MAY CAUSE DAMAGE TO TISSUE OR THE DEVICE. ¿ INSPECT THE WIRE GUIDE FOR KINKS OR DAMAGE PRIOR TO USE. EVIDENCE GATHERED UPON REVIEW OF DMR, PRODUCT LABELING, AND DEVICE FAILURE ANALYSIS, DOES NOT INDICATE THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION. THERE IS NO EVIDENCE OF NONCONFORMING MATERIAL IN HOUSE OR IN THE FIELD. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED AND THE RESULTS OF OUR INVESTIGATION, IT WAS CONCLUDED THAT A COMPONENT FAILURE UNRELATED TO MANUFACTURING OR DESIGN DEFICIENCIES CONTRIBUTED TO THE REPORTED EVENT. IT IS UNKNOWN IF THE WIRE WAS WITHDRAWN WHILE INSIDE THE NEEDLE OR IF THE PATIENT HAD TORTUOUS ANATOMY. BOTH COULD HAVE CAUSED DAMAGE TO THE WIRE GUIDE RESULTING IN THE RESISTANCE AND UNCOILING. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. 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

    IT WAS REPORTED THAT THE WIRE GUIDE FROM AN UNKNOWN COOK WAYNE PNEUMOTHORAX SET SEPARATED. THE DEVICE WAS INSERTED BY A PHYSICIAN WITH THE HELP OF ANOTHER DOCTOR IN THE EMERGENCY ROOM (ER). DURING THE PROCEDURE, THE WIRE GUIDE FRACTURED, AND A PIECE OF THE WIRE WAS RETAINED IN THE CHEST TUBE. THE CHEST TUBE AND WIRE WERE REMOVED FROM THE PATIENT, AND NEW CHEST TUBE WAS PLACED TO COMPLETE THE PROCEDURE. THE COMPLAINT DEVICE PACKAGING WAS DISCARDED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1619188 UNKNOWN JOL CATHETER AND TIP, SUCTION JOL COOK INC UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female