MAUDE Adverse Event Report: COOK, INC. THAL-QUICK CHEST TUBE SET; DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number C-TQTS-2400

Device Problem Material Separation (1562)

Patient Problem Surgical procedure, additional (2564)

Event Date 09/11/2014

Event Type  Injury  

Event Description

During a treatment procedure on a (b)(6) male patient, the drain snapped at the distal end, while inside the patient.The chest drain was inside patients left lung; no procedure or movement occurred to cause fault of drain falling apart and disconnecting.There was no harm to the patient; however, an emergency procedure for re-insertion of another chest drain in the same location had to be performed.Additional information stated that in the left lung, a size 24 thal-quick chest drain had been inserted for several days.The drain disconnected at distal port into 2 pieces at the female connection end.This part of chest drain is manufactured as one piece and should not come apart.An emergency procedure to reinflate lung and prevent cardiac arrest was performed successfully and a new drain reinserted.

Manufacturer Narrative

(b)(4).The device will not be returned for investigation.The description of event states, "the drain disconnected at distal port into 2 pieces at the female connection end.This part of chest drain is manufactured as one piece and should not come apart." we believe the user is meaning that the hub separated from the chest tube.A review of complaint history, quality control, and trends was conducted during the investigation.There is no evidence to suggest the device was not manufactured per specifications.The device is inspected during quality control with a 100% verification of the fitting to the tubing.The device is supplied with instructions for use (ifu) which describes the appropriate uses, warnings and precautions, and placement techniques.The complaint device was not returned for investigation.Based on the description of event, we believe that the hub separated from the chest tube during use.The user stated, "no procedure or movement occurred to cause fault of drain falling apart and disconnecting." unfortunately, a definitive root cause cannot be determined at this time.Per the conclusion of quality engineering risk assessment, additional risk mitigating action is not required at this time.The occurrence rate is 0.004%.In this particular case, harm to the patient was determined to be minor harm to patient.We have notified appropriate internal personnel and will continue to monitor for similar complaints.

• Brand Name: THAL-QUICK CHEST TUBE SET
• Type of Device: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK, INC.; p.o. box 489; bloomington IN 47404
• Manufacturer Contact: rita harden, director ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4196360
• MDR Text Key: 16780610
• Report Number: 1820334-2014-00555
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: GB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 09/16/2014

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
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2016
• Device Catalogue Number: C-TQTS-2400
• Device Lot Number: 4674088
• Other Device ID Number: 00827002041370(17)161201(10)46
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/11/2014
• Device Age: 2 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/16/2014
• Initial Date FDA Received: 10/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR