MAUDE Adverse Event Report: COOK, INC. WAYNE PNEUMOTHORAX TRAY; JOL CATHETER AND TIP, SUCTION

Model Number N/A

Device Problems Valve(s), failure of (1672); Appropriate Term/Code Not Available (3191)

Patient Problems Other (for use when an appropriate patient code cannot be identified) (2200); No Code Available (3191)

Event Type  Injury  

Event Description

Per the medwatch form (b)(4): a male patient with a radiographically confirmed pneumothorax underwent percutaneous placement of a 14 french pigtail catheter; which includes a one way heimlich valve.A chest x-ray performed immediately after the procedure demonstrated appropriate positioning of the pleural catheter, but internal enlargement of the pneumothorax and development of radiographic features of tension pneumothorax.The patient's clinical condition remained stable.An examination of the chest tube assembly revealed reversal of the intended orientation of the heimlich valve.The valve was reinstalled in the correct location, and a repeat x-ray revealed resolution of the pneumothorax and all radiographic features of tension pneumothorax.The patient was admitted for further management.The heimlich valve is often used with thoracostomy tubes and other medical devices requiring unidirectional flow.The heimlich valve is a simple mechanical valve, consisting of a flexible and collapsible tube inside a cylindrical changer, positive pressure through one end of the valve creates flow through the flexible tube.Negative pressure collapses the tube, preventing flow reversal.The result is a one way valve.The patient's normal respirations create the positive and negative pressure cycle, pumping air or fluid out of the pleural space when the valve is properly positioned.Advantages of the valve include a simple design that does not require the application of a powered suction device and low cost.Patients with pneumothoraces and thoracostomy tubes can be transported or can be ambulatory while disconnected from wall suction with a heimlich valve attached to the thoracostomy tube.In some cases, patient's are even discharged from the hospital with thoracostomy tubes and heimlich valves in place.The design of a heimlich valve mandates unidirectional flow, the direction of which is determined by the orientation of the valve.Reversal of the valve results in the entrainment of atmospheric air through the tube into the pleural space when the patient inspires.That air is then trapped within the pleural space and cannot escape through the heimlich valve.Within a short period of time the accumulation of air in the pleural space can lead to an enlarging pneumothorax as in the patient described.Failure of healthcare providers to recognize the error and correct the valve orientation could result in clinical tension pneumothorax and death.Reversal of the intended valve orientation is possible at the time of initial insertion, during tube manipulation by medical staff (nurse, physicians, or other), or even by patient's, some of whom may not be under medical supervision.The heimlich valve included in the wayne pneumothorax tray is symmetrically designed, with conical "christmas tree" adaptors at each end, consequently, the valve can be inserted in the incorrect orientation into the included thoracostomy tube adaptor, which terminates in a funnel shaped opening.The device could be redesigned with asymmetrical connections, preventing incorrect insertion.Labels on the device correctly indicate the direction of low but are ambiguous and difficult to read.The valve itself bears no warning of the potentially dire consequences of improper orientation.An explicit warning label could be added to the valve within the kit to draw attention to the correct orientation and risks.The manufacturer instructions for valve insertion are ambiguous and brief and could be improved with figures and explicit warnings.Instructions for patients and first responders about the risks of the valve are also needed, particularly given that the valve may be used in an outpatient setting.

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.(b)(4).Investigation - evaluation a review of complaint history, documentation, drawing, instructions for use (ifu), and quality control and was conducted during the investigation.The device is shipped with an instruction for use (ifu) that describes the intended use, specific items are addressed such as: ¿attach chest drain valve in direction indicated by arrow on valve." internal documents specify that the adapter and cap are to be clue in color, while the body and valve are natural in color (i.E.No color added) the blue adapter and cap are to be attached to the patient's chest tube and the natural end is attached to the collection device specified by the health care provider.This is consistent with competing devices in the field.The device is marked with arrows indicating direction of flow and instructions for the correct end to attach the device to the patient's chest tube.As part of this investigation, an internet search was conducted to determine what chest drain valves by other manufacturers look like and if there is a better way to indicate orientation of the valve.The search revealed that other competitive devices are also manufactured with a blue end which is to be connected to the patient's chest tube and a natural/clear end which is to be connected to the health care provider specified collection device.In addition, multiple patient guides provided by hospitals indicate that in the event that the chest drain valve is disconnected that the patient should attach the blue or colored end to their chest tube.Based on this search, it appears that the cook device is similar to competitive devices and health care provider published literature in how color is used to indicate orientation in addition to arrows on the body of the device to indicate direction of flow.The complaint device was not returned; therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It is possible to suggest that the root cause of this incident is failure to follow the ifu and instructions for orientation on the device.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.Per the quality engineering risk assessment (qera) no further action is required.

Event Description

Per the medwatch form (mw5040515): a male patient with a radiographically confirmed pneumothorax underwent percutaneous placement of a 14 french pigtail catheter; which includes a one way heimlich valve.A chest x-ray performed immediately after the procedure demonstrated appropriate positioning of the pleural catheter, but internal enlargement of the pneumothorax and development of radiographic features of tension pneumothorax.The patients clinical condition remained stable.An examination of the chest tube assembly revealed reversal of the intended orientation of the heimlich valve.The valve was reinstalled in the correct location, and a repeat x-ray revealed resolution of the pneumothorax and all radiographic features of tension pneumothorax.The patient was admitted for further management.

• Brand Name: WAYNE PNEUMOTHORAX TRAY
• Type of Device: JOL CATHETER AND TIP, SUCTION
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 4875008
• MDR Text Key: 5861388
• Report Number: 1820334-2015-00351
• Device Sequence Number: 1
• Product Code: JOL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2016
• Device Model Number: N/A
• Device Catalogue Number: C-UTPTY-1400-WAYNE-112497
• Device Lot Number: 5020866
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/25/2015
• Event Location: Hospital
• Date Manufacturer Received: 05/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention