BEUDAMED
    FDA Adverse Event Death Summary report: N

    BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET

    MDR report key: 13764822 · Received March 14, 2022

    Report

    Report Number
    1820334-2022-00391
    Event Type
    Death
    Date Received
    March 14, 2022
    Report Date
    December 22, 2022
    Manufacturer
    COOK INC
    Product Code
    JOH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CATALOG# (RPN): SUSPECT PRODUCT IS C-PTISY-100-HC-G-NA. PMA/510(K) #: K193133. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    CORRECTION: H6 - ANNEX G. INVESTIGATION ¿ EVALUATION. ON (B)(6) 2022, (B)(6) CENTER (UNITED STATES) REPORTED THAT UNKNOWN COMPLICATIONS OCCURRED WITH A BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET (RPN: UNKNOWN; LOT#: UNKNOWN). PATIENT DEATH WAS INDICATED. THE PHYSICIAN NOTED THAT HE DOES NOT BELIEVE THE COMPLICATIONS ARE RELATED TO EQUIPMENT ISSUES. ADDITIONALLY, THE PHYSICIAN STATED THAT AN INTERNAL REVIEW WOULD BE PERFORMED, AND THE FDA AND COOK WOULD BE ALERTED IF A DEVICE ISSUE WAS DISCOVERED. NO OTHER INFORMATION WAS MADE AVAILABLE. REVIEWS OF THE DEVICE HISTORY RECORD (DHR) AND INSTRUCTIONS FOR USE (IFU) OF 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. THE EXACT RPN IS UNKNOWN; HOWEVER, IT WAS REPORTED A POSSIBLE RPN IS C-PTISY-100-HC-G-NA. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. A SALES SEARCH FOUND ONLY LOTS 14287976 AND 14452900 WERE SOLD TO THE CUSTOMER. A REVIEW OF THE DHRS FOR THE DISCOVERED LOTS REVEALED NO RELEVANT NON-CONFORMANCES. A DATABASE SEARCH IDENTIFIED TWO OTHER EVENTS REPORTED BY THE SAME HOSPITAL, AT THE SAME TIME AS THIS EVENT. IN BOTH COMPLAINTS IT WAS REPORTED THAT THE CUSTOMER DID NOT BELIEVE THE COMPLICATIONS WERE RELATED TO EQUIPMENT ISSUES. 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 FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THIS DEVICE IS SUPPLIED WITH AN IFU, C_T_PTISGI2_REV0 (BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER), WHICH PROVIDES THE PROPER INSTRUCTIONS FOR USE. BASED ON THE AVAILABLE INFORMATION, NO DEVICE RETURN, AND THE RESULTS OF THE INVESTIGATION, THIS COMPLAINT IS NOT CONFIRMED. THE CUSTOMER RESPONDED TO COOK¿S REQUEST FOR ADDITIONAL INFORMATION STATING THEY COULD NOT PROVIDE ANSWERS AS THEY ARE PERFORMING AN INTERNAL QUALITY IMPROVEMENT REVIEW OF THE COMPLICATIONS. THE CUSTOMER STATED THEY ARE NOT SURE IF THERE WERE ANY EQUIPMENT ISSUES. NO FAILURE OF THE PRODUCT WAS MENTIONED. 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 AN UNKNOWN COMPLICATION WAS EXPERIENCED WITH AN UNKNOWN BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET. PATIENT DEATH WAS INDICATED. THE PHYSICIAN NOTED, AT THIS TIME, THE COMPLICATIONS ARE NOT BELIEVED TO BE RELATED TO THE DEVICE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE. THE PHYSICIAN STATED THAT INFORMATION WILL BE PROVIDED FOLLOWING THE FACILITY'S INTERNAL REVIEW.

    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
    38467 BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET JOH TUBE TRACHEOSTOMY AND TUBE CUFF JOH COOK INC N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death