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

Model Number	G56537
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Cook medicals "wayne pneumothorax tray" c-utpty-1400-wayne-112497-imh, g56637, lot # 14121501.The tray has a heimlich valve in it that was incorrectly inserted backwards by provider and did not allow air to exit chest/pleural space and resulted in worsening of patient's pneumothorax.The heimlich valve does not have markings on it that are easy to read and are of the same color (clear plastic).There is a disposable paper diagram that was not clear to provider during urgent implantation of how to attach to catheter/tubing.No other instructions for use were present in the kit.Fda safety report id# (b)(4).

• Brand Name: WAYNE PNEUMOTHORAX TRAY
• Common Device Name: CATHETER AND TIP, SUCTION
• Manufacturer (Section D): COOK MEDICAL / COOK, INC.; bloomington IN 47404
• MDR Report Key: 14195101
• Report Number: MW5109326
• Device Sequence Number: 5308976
• Product Code: JOL
• UDI-Device Identifier: 00827002565371
• UDI-Public: (01)00827002565371(17)220701(10)
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: G56537
• Device Catalogue Number: C-UTPTY-1400-WAYNE-112497-IMH
• Device Lot Number: 14121501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/22/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 31 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White