MAUDE Adverse Event Report: COOK INCORPORATED COOK CHEST TUBE, 14 FRENCH MAC-LOC; CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Device Problem Disconnection (1171)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/01/2020

Event Type  malfunction  

Event Description

The patient's chest tube hub snapped off from the pigtail itself, revealing the wires and disconnecting the patient from suction.The remaining pigtail was immediately clamped and service was called.Service came to bedside and decided to fully remove the chest tube, as there was no way to reconnect the tube to suction.

• Brand Name: COOK CHEST TUBE, 14 FRENCH MAC-LOC
• Type of Device: CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INCORPORATED; 1100 w morgan st; spencer IN 47460
• MDR Report Key: 9726535
• MDR Text Key: 179956322
• Report Number: 9726535
• Device Sequence Number: 1
• Product Code: GBO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/05/2020
• Event Location: Hospital
• Date Report to Manufacturer: 02/19/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1