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

Model Number	N/A
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	04/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient required a wayne pneumothorax tray for a chest tube placement.After placement, it was discovered the user had inserted the chest drain valve backwards, not allowing air to exit the chest/pleural space.This resulted in worsening of the patient's pneumothorax.It is not known at this time how much time elapsed from placement until discovery and what specific interventions were performed.The device was explanted on (b)(6) 2022.No other adverse effects were reported for this incident.Additional information regarding the event and patient outcome has been requested but is currently unavailable.
Additional Manufacturer Narrative
Occupation: risk manager.Pma/510(k) #: exempt.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Correction: h6 - annex a.Investigation ¿ evaluation.It was reported by presbyterian health service corp (united states) that on 13apr2022 the chest drain valve in a wayne pneumothorax tray (rpn: c-utpty-1400-wayne-112497-imh; lot#: 14121501) was placed backwards.As a result, the patient¿s pneumothorax worsened.The device was explanted on (b)(6) 2022.No other adverse effects were reported due to this occurrence.Reviews of the complaint history, device history record (dhr), quality control, specifications, and instructions for use (ifu), 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 master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhr for the reported complaint device lot 14121501 and related sub-assembly lots revealed no recorded non-conformances.A database search did not identify any other events associated with the reported device 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 field.Cook also reviewed product labeling.The ifu (c_t_waynemod_rev5) supplied with the complaint lot states the following in consideration of the reported failure mode: ¿instructions for use: 9.Remove the wire guide and catheter obturator.Attach connecting tube with stopcock, and cook chest drain valve.Attach cook chest drain valve in direction indicated by arrow on valve.Note: chest drain valve may be obviated if catheter is to be connected to a water seal suction apparatus or similar mechanical suction device.Do not connect catheter directly to wall suction.How supplied: upon removal from package, inspect the product to ensure no damage has occurred.¿ this product is supplied with an additional label attached to the chest drain valve indicating the correct direction to attach the connecting tube.Based on the available information, no device return, and the results of the investigation, the root cause for this event is user error.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.

• Brand Name: WAYNE PNEUMOTHORAX TRAY
• Common Device Name: JOL CATHETER AND TIP, SUCTION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 14658820
• Report Number: 1820334-2022-01043
• Device Sequence Number: 3739827
• Product Code: JOL
• UDI-Device Identifier: 00827002565371
• UDI-Public: (01)00827002565371(17)220701(10)14121501
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/01/2022
• Device Model Number: N/A
• Device Catalogue Number: C-UTPTY-1400-WAYNE-112497-IMH
• Device Lot Number: 14121501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: 05/25/2022
• Supplement Date Received by Manufacturer: 11/28/2022
• Initial Report FDA Received Date: 06/10/2022
• Supplement Report FDA Received Date: 12/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown