CLOSED SUCTION CATHETER
Report
- Report Number
- 8030647-2017-00035
- Event Type
- Death
- Date Received
- January 20, 2017
- Date of Event
- January 29, 2017
- Report Date
- July 25, 2017
- Manufacturer
- HALYARD HEALTH
- Product Code
- BSY
- PMA / PMN Number
- UNKNOWN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
B5: ADDITIONAL INFORMATION. B3: CORRECTION: 23-DEC-2016. D4: CORRECTION: LOT NUMBER UNKNOWN. ALL INFORMATION REASONABLY KNOWN AS OF 24 AUG 2017 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY HALYARD HEALTH REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO HALYARD HEALTH. HALYARD HEALTH HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A HALYARD HEALTH PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.
B5: ADDITIONAL INFORMATION. B3: CORRECTION: 23-DEC-2016. D4: CORRECTION: LOT NUMBER UNKNOWN. ALL INFORMATION REASONABLY KNOWN AS OF 24AUG2017 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY HALYARD HEALTH REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO HALYARD HEALTH. HALYARD HEALTH HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A HALYARD HEALTH PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.
IT WAS REPORTED THAT THE CUSTOMER STATED THAT, A HISPANIC MALE WITH A (DNR) DO NOT RESUSCITATE PATIENT WITH AN ANOXIC BRAIN INJURY POST CARDIAC ARREST. PEA (PULSELESS ELECTRICAL ACTIVITY) VEGETATIVE STATE. IT WAS REPORTED THAT THE CUSTOMER WAS UNABLE TO PROVIDE THE EXACT LOT THE PRODUCT CAME FROM.
IT WAS REPORTED THAT THE CUSTOMER STATED THAT, A HISPANIC MALE WITH A (DNR) DO NOT RESUSCITATE PATIENT WITH AN ANOXIC BRAIN INJURY POST CARDIAC ARREST. PEA (PULSELESS ELECTRICAL ACTIVITY) VEGETATIVE STATE. IT WAS REPORTED THAT THE CUSTOMER WAS UNABLE TO PROVIDE THE EXACT LOT THE PRODUCT CAME FROM.
CORRECTION: MDR WAS SUBMITTED AS 8030647-2017-00035 BUT THE CORRECT NUMBER SHOULD HAVE BEEN 8030647-2017-00004. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER, M6287T606, INVOLVED IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. THE ACTUAL PRODUCT SAMPLE WAS NOT RETURNED FOR EVALUATION. THE DIRECTIONS FOR USE WHICH ACCOMPANIES EVERY DEVICE STATES UNDER THE SECTION TITLED WARNING: "CAP ON HALYARD T-PIECE PREVENTS CONTINUOUS FLOW THERAPY. REMOVE CAP BEFORE STARTING CONTINUOUS FLOW THERAPY. FAILURE TO REMOVE CAP PRIOR TO CONTINUOUS FLOW THERAPY MAY RESULT IN SERIOUS INJURY OR DEATH." ALL INFORMATION REASONABLY KNOWN AS OF 10APR2017 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY HALYARD HEALTH REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO HALYARD HEALTH. HALYARD HEALTH HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).
THE ACTUAL PRODUCT SAMPLE WAS NOT RETURNED FOR EVALUATION. THE DIRECTIONS FOR USE WHICH ACCOMPANIES EVERY DEVICE STATES UNDER THE SECTION TITLED WARNING: "CAP ON HALYARD T-PIECE PREVENTS CONTINUOUS FLOW THERAPY. REMOVE CAP BEFORE STARTING CONTINUOUS FLOW THERAPY. FAILURE TO REMOVE CAP PRIOR TO CONTINUOUS FLOW THERAPY MAY RESULT IN SERIOUS INJURY OR DEATH." HALYARD HEALTH HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). DEVICE NOT RETURNED.
ADDITIONAL INFORMATION WAS RECEIVED ON 15-FEB-2017 THAT STATES, A MEDWATCH REPORT 5067603 LISTS THE REPORT DATE LISTED AS 29-JAN-2017. ADDITIONAL INFORMATION STATES "A NURSE REMOVED THE INLINE SUCTION CATHETER ON THE VENTILATOR AND PLACED ON THE PATIENT, BUT FAILED TO REMOVE THE CAP LEADING TO THE PATIENT'S ARREST. AFTER A ROOT CAUSE ANALYSIS OF THE SITUATION, THE NURSE FEELS THAT IF THE CAP HAD BEEN RED OR IF IT STATED "REMOVE FOR T-PIECE" IT MIGHT HAVE PREVENTED THE HUMAN ERROR. NO ADDITIONAL INFORMATION RECEIVED.
IT WAS REPORTED BY A HOSPITAL REPRESENTATIVE THAT, ¿WE HAD A PATIENT DEATH. THE DEATH RESULTED FROM MISUSE OF THE IN LINE SUCTION CATHETER. THE CATHETER WAS REMOVED FROM THE VENTILATOR CIRCUIT AND HOOKED UP TO THE CORRUGATED HUMIDIFIED OXYGEN TUBING IN AN ATTEMPT TO CONVERT IT TO A T PIECE. THE WHITE CAP WAS NOT REMOVED BY THE NURSE CAUSING THE PATIENT TO RE-BREATH INTO THE TUBING AND HAVE RESPIRATORY DE-COMPENSATION.¿ NO FURTHER INFORMATION PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 50921 | CLOSED SUCTION CATHETER | VAP CLOSED SUCTION CATHETERS & ACCESSORIE | BSY | HALYARD HEALTH | UNKNOWN | M6287T606 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Male | Death |