MAUDE Adverse Event Report: COOK INC. MULTIPURPOSE DRAINAGE CATHETER SET; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number REF GO6484

Device Problems Break (1069); Disconnection (1171); Application Program Problem: Medication Error (3198)

Patient Problem Anxiety (2328)

Event Date 06/05/2017

Event Type  malfunction  

Event Description

Rn returned to patient room and found chest tube disconnected.After clamping tube, rn found the tube to be broken off at the junction of the tube and the stopcock.Physician notified and believes may be a manufacturing issue with the chest tube.Rn believes this may be related to the patient's agitation and withdrawal symptoms.

• Brand Name: MULTIPURPOSE DRAINAGE CATHETER SET
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INC.; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6646257
• MDR Text Key: 77719765
• Report Number: 6646257
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/12/2017

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
• Device Model Number: REF GO6484
• Device Lot Number: 77538598X OR 7726482
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/12/2017
• Event Location: Hospital
• Date Report to Manufacturer: 06/12/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NONE THAT CONTRIBUTED TO EVENT
• Patient Age: 50 YR
• Patient Weight: 32