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

Model Number	N/A
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	08/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E3 - occupation: trauma program director, rn, msn, tcrn.G4 - 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.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
It was reported that the obturator was inadvertently left inside of the catheter included in the wayne pneumothorax tray following chest tube placement in a 22-year-old male trauma patient.The patient was taken to interventional radiology (ir) for a chest tube placement procedure; however, it was reported that the pneumothorax persisted despite treatment.During a replacement procedure on (b)(6) 2023, it was discovered that the obturator had been retained in the original chest tube.The ir nurse noted that prior to the start of the initial placement procedure, the obturator was already in place and likely never removed.It was later reported that the chest tube could be luer locked onto suction with the obturator in place, most likely leading to the technical error by the trauma surgeon.
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 unchanged, unknown, or unavailable.Investigation ¿ evaluation.It was reported that the straightening obturator in a wayne pneumothorax tray was retained in the catheter after completion of the procedure.The device was placed in the patient by a trauma surgeon for treatment of a pneumothorax.However, after the device was placed the pneumothorax persisted.The patient was sent to interventional radiology (ir) to have the device replaced.At this time, the ir nurse identified that the straightening obturator was retained in the catheter.The event also resulted in prolonged hospitalization for the patient.No other adverse events were reported.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control procedures of 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.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify any potential non-conformances prior to distribution.A review of the dhr for the reported complaint device lot and related sub-assembly lots revealed no recorded non-conformances.A complaint history 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 the field.Cook reviewed product labeling.This product is supplied with an instructions for use (ifu) pamphlet, c_t_waynemod_rev5.Instructions for use: 7.) attach plastic three-way stopcock to the catheter obturator.Fully straighten the curved catheter tip by advancing the catheter obturator.When fully advanced, attach the obturator to the catheter via the luer lock connection.8.) advance the catheter over the wire guide into the pleural cavity to the desired depth.Depth may be guided by the 2.5 cm markings on the catheter.The first mark begins 5 cm from the last side hole.9.) remove the wire guide and catheter obturator.Attach catheter to 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.Based on the information provided, no device return, and the results of the investigation, the cause for this event is failure to follow the ifu.The product labeling states that once the catheter is placed, the obturator should be removed.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: 17760010
• Report Number: 1820334-2023-01248
• Device Sequence Number: 15256411
• Product Code: JOL
• UDI-Device Identifier: 00827002565371
• UDI-Public: (01)00827002565371(17)250403(10)15504623
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/03/2025
• Device Model Number: N/A
• Device Catalogue Number: C-UTPTY-1400-WAYNE-112497-IMH
• Device Lot Number: 15504623
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: 09/01/2023
• Supplement Date Received by Manufacturer: 03/12/2024
• Initial Report FDA Received Date: 09/15/2023
• Supplement Report FDA Received Date: 04/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2023
• 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: Required Intervention; Hospitalization; Life Threatening
• Patient Age: 22 YR
• Patient Sex: Male
• Patient Weight: 57 KG