MAUDE Adverse Event Report: COOK, INC. THAL-QUICK CHEST TUBE TRAY; GBX CATHETER, IRRIGATION

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Surgical procedure, additional (2564)

Event Date 06/22/2015

Event Type  Injury  

Event Description

On (b)(6) 2015, a wayne pneumothorax tube was placed at 8cm inside the patient.On (b)(6) 2015 the device was noted to be out of pleural space via ct scan (mdr#1820334-2015-00454) and a thai-quick chest tube was placed.On (b)(6) 2015, it was noted the thai-quick was out of place via ct scan (1820334-2015-00470) and a multipurpose drainage catheter was placed.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).This event is currently under investigation.

Manufacturer Narrative

(b)(4).Investigation/evaluation: during the course of the investigation, a review of the complaint history, quality control, trends, instructions for use (ifu), manufacturing instructions, and drawing was conducted.There is no evidence to suggest that the device was not manufactured to specifications.The device is packaged with ifu.The ifu gives the device description, intended use, warnings, precautions and instructions for placement and use of the device.Without the return of the complaint device or product information to examine production records, the root cause of this complaint is inconclusive.Per the quality engineering risk assessment, no further action is required.We have notified appropriate internal personnel and will continue to monitor for similar events.

Event Description

On (b)(6) 2015, a wayne pneumothorax tube was placed at 8cm inside the patient.On (b)(6) 2015 the device was noted to be out of pleural space via ct scan (mdr# 1820334-2015-00454) and a thal-quick chest tube was placed.On (b)(6) 2015, it was noted the thal-quick was out of place via ct scan (1820334-2015-00470) and a multipurpose drainage catheter was placed.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: THAL-QUICK CHEST TUBE TRAY
• Type of Device: GBX CATHETER, IRRIGATION
• Manufacturer (Section D): COOK, INC.; bloomington IN 47402
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4947092
• MDR Text Key: 6257414
• Report Number: 1820334-2015-00470
• Device Sequence Number: 1
• Product Code: GBX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-TQTSY-2000
• Other Device ID Number: SEE H.10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/22/2015
• Device Age: NA
• Event Location: Hospital
• Date Manufacturer Received: 07/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Weight: 91