WAYNE PNEUMOTHORAX TRAY CHEST TUBE G56537

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-12-31 for WAYNE PNEUMOTHORAX TRAY CHEST TUBE G56537 manufactured by Cook Incorporated.

Event Text Entries

[173648835] Presented to er for chest pain and sob after lifting weights. Cxr showed large left-sided pneumonia. Chest tube replaced. Post cxr showed re-expansion of the left lung. Early following am (b)(6) 2019, large constant air leak noted from chest tube. Was discovered the tubing from the suction had become disconnected (found the suction had been connected to an internal stiffener stylet inside the chest tube which has slid out leaving the circuit disconnected and chest tube at left chest wall to air). The stiffener stylet was discarded and the suction was reattached decreasing the air leak. Cxr showed right hand interval increase in small left apical pneumothorax. Continue with persistent air leak due to failure of non operative tx. On (b)(6) 2019 to surgery for bilateral vats, bleb resection, pleurectomy, and pleurodesis. Ongoing treatment. Reporting concern regarding the design of the chest tube that allows the trocar / stylet to be forced into the chest tube which allows the trocar / stylet to be able to be screwed to / leur locked onto the chest tube itself leaving open risk for error when inserting to be the chest tube leading to large leaks and ineffectiveness / malfunction of the chest tube, if the trocar / stylet was attached and left in the chest tube in error in the process of insertion. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5091964
• MDR Report Key: 9539116
• Date Received: 2019-12-31
• Date of Report: 2019-12-27
• Date of Event: 2019-08-15
• Date Added to Maude: 2020-01-02
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: WAYNE PNEUMOTHORAX TRAY CHEST TUBE
• Generic Name: CATHETER AND TIP, SUCTION
• Product Code: JOL
• Date Received: 2019-12-31
• Catalog Number: G56537
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: COOK INCORPORATED
• Manufacturer Address: BLOOMINGTON IN 47404 US 47404

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2019-12-31