BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOH TUBE TRACHEOSTOMY AND TUBE CUFF

    MDR report key: 17374110 · Received July 21, 2023

    Report

    Report Number
    1820334-2023-00953
    Event Type
    Injury
    Date Received
    July 21, 2023
    Date of Event
    September 14, 2021
    Report Date
    March 27, 2024
    Manufacturer
    COOK INC
    Product Code
    JOH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. E3 - OCCUPATION: MANAGER. 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

    IT WAS REPORTED THAT A PATIENT REQUIRED AN ADDITIONAL OPEN TRACHEOSTOMY PROCEDURE AFTER USE OF AN UNKNOWN BLUE RHINO PERCUTANEOUS TRACHEOSTOMY DEVICE. THE DEVICE WAS REQUIRED FOR A PERCUTANEOUS TRACHEOSTOMY PROCEDURE IN THE CRITICAL CARE UNIT. DURING THE PROCEDURE, THE 14FR PUNCH DILATOR AND THE WIRE GUIDE BENT. THE TRACHEOSTOMY TUBE WAS IN PLACE FOR ABOUT THREE HOURS. THEN THE PATIENT REQUIRED AN ADDITIONAL OPEN TRACHEOSTOMY PROCEDURE. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT. REVIEWS OF THE INSTRUCTIONS FOR USE AND QUALITY CONTROL PROCEDURES FOR THE DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. IN RESPONSE TO THIS INCIDENT, COOK COMPLETED A REVIEW OF THE PRODUCT DEVICE MASTER RECORD WHICH CONTAINS QUALITY INSPECTIONS TO IDENTIFY ANY NON-CONFORMING MATERIAL BEFORE SHIPPING. COOK CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE CUSTOMER DID NOT PROVIDE THE LOT NUMBER FOR THE COMPLAINT DEVICES. COOK REVIEWED THE SALES HISTORY FOR THIS CUSTOMER AND WAS UNABLE TO IDENTIFY THE COMPLAINT LOT. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. COOK ALSO REVIEWED PRODUCT LABELING. THE PRODUCT IFU, [C_T_PTISG_REV4] ¿CIAGLIA BLUE RHINO G2 ADVANCED PERCUTANEOUS TRACHEOSTOMY INTRODUCER,¿ PROVIDES INSTRUCTIONS FOR PROPER DEVICE USAGE. THE INFORMATION PROVIDED UPON REVIEW OF DEVICE MASTER RECORD AND PRODUCT LABELING 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 DEVICE RETURN, AND THE RESULTS OF THE INVESTIGATION, COOK WAS UNABLE TO ESTABLISH A CAUSE FOR THIS EVENT. NO INFORMATION ABOUT THE PATIENT WAS PROVIDED. IT IS UNKNOWN WHY THE PATIENT REQUIRED AN ADDITIONAL OPEN TRACHEOSTOMY PROCEDURE. DIFFICULTY WITH THE 14 FR PUNCH DILATOR AND WIRE GUIDE WAS REPORTED; HOWEVER, THE DEVICE WAS ULTIMATELY PLACED AND REMAINED IN THE PATIENT FOR THREE HOURS. THEREFORE, IT IS UNLIKELY THE EVENT WITH THE PUNCH DILATOR AND WIRE CONTRIBUTED TO THE NEED FOR AN ADDITIONAL PROCEDURE. THE DOCTOR WAS NOT AVAILABLE TO EXPLAIN WHY THE PATIENT NEEDED AN ADDITIONAL OPEN TRACHEOSTOMY PROCEDURE. 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 A PATIENT REQUIRED AN ADDITIONAL OPEN TRACHEOSTOMY PROCEDURE AFTER USE OF AN UNKNOWN BLUE RHINO PERCUTANEOUS TRACHEOSTOMY DEVICE. THE DEVICE WAS REQUIRED FOR A PERCUTANEOUS TRACHEOSTOMY PROCEDURE IN THE CRITICAL CARE UNIT. DURING THE PROCEDURE THE 14FR PUNCH DILATOR AND THE WIRE GUIDE BENT. THE TRACHEOSTOMY TUBE WAS IN PLACE FOR ABOUT THREE HOURS. THEN THE PATIENT REQUIRED AN ADDITIONAL OPEN TRACHEOSTOMY PROCEDURE. 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
    1587409 JOH TUBE TRACHEOSTOMY AND TUBE CUFF JOH COOK INC N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention