BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GCB NEEDLE, CATHETER

    MDR report key: 22318586 · Received June 24, 2025

    Report

    Report Number
    1820334-2025-00757
    Event Type
    Injury
    Date Received
    June 24, 2025
    Report Date
    January 22, 2026
    Manufacturer
    COOK INC
    Product Code
    GCB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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 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 OR THAT A DEATH OR SERIOUS INJURY OCCURRED; NOR IS IT ADMISSION THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION. IT WAS REPORTED THAT, DURING A CHEST TUBE PLACEMENT PROCEDURE, THE SOFT DISTAL TIP (4MM FRAGMENT) OF A NEEDLE'S PLASTIC OUTER CATHETER WAS SHEARED OFF AND REMAINED WITHIN THE PATIENT'S PLEURAL SPACE. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT. THE CUSTOMER DID NOT PROVIDE AN RPN FOR THE COMPLAINT DEVICE. BASED ON REVIEW OF OVERALL SALES, COOK ASSUMED THIS DEVICE TO BE A YUEH CENTESIS CATHETER NEEDLE FOR THIS INVESTIGATION. REVIEWS OF DOCUMENTATION INCLUDING QUALITY CONTROL PROCEDURES FOR THE DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS UNABLE TO BE COMPLETED DUE TO A LACK OF LOT INFORMATION. AN EXPANDED SALES SEARCH FOR THIS CUSTOMER WAS UNABLE TO IDENTIFY THE COMPLAINT LOT. BASED ON THE AVAILABLE INFORMATION, COOK HAS CONCLUDED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION AND THAT THERE IS NO EVIDENCE SUGGESTING NONCONFORMING PRODUCT EXISTS EITHER IN HOUSE OR IN THE FIELD. COOK DID NOT REVIEW PRODUCT LABELING. THIS DEVICE IS NOT PACKAGED WITH INSTRUCTIONS FOR USE. BASED ON THE LIMITED INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, COOK WAS UNABLE TO ESTABLISH A CAUSE FOR THIS EVENT. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. 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 DURING A CHEST TUBE PLACEMENT PROCEDURE, THE SOFT DISTAL TIP (4MM FRAGMENT) OF A NEEDLE'S PLASTIC OUTER CATHETER WAS SHEARED OFF AND REMAINED WITHIN THE PATIENT'S PLEURAL SPACE. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

    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
    1568066 GCB NEEDLE, CATHETER GCB COOK INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown