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

Model Number N/A

Device Problem Material Separation (1562)

Patient Problems Bacterial Infection (1735); Pleural Effusion (2010); No Code Available (3191)

Event Date 12/30/2020

Event Type  Injury  

Manufacturer Narrative

Reporter occupation: clinical risk specialist.Pma/510(k) #: exempt.(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported that a separation occurred at the junction of the funnel connector and the catheter lumen of a thal-quick chest tube set.On (b)(6) 2020, a (b)(6) year old patient was admitted for trauma to the chest in which a 20 fr thal-quick chest tube was placed in the left anterior third rib space.On (b)(6) 2020, the chest tube was knocked over twice.Chambers were then refilled to proper volumes.It was noted that the chest tube connections became dislodged at the site where the tubes were connected via a zip tie.The next day on (b)(6) 2020, the patient managed to disconnect the tubing of their device while getting out of bed.Per the nurse, the chest tube became dislodged at the joint between the tubes.On (b)(6) 2021 the patient reportedly "knocked over his chest tube." a chest x-ray interpreted on (b)(6) 2021 at 0715 noted "increasing opacity in the left lung which may be related to atelectasis from the enlarging pleural effusion." video-assisted thoracoscopic surgery (vats), mild decortication and wash out were then completed.Per the physician, the tube was originally wrapped in tape.When the or staff removed the tape, it was noted that the tube was not connected.The physician believes this area of the tube should not come apart in this fashion and does not believe it to be due to user error.On (b)(6) 2021, the patient was diagnosed with empyema of the pleural space.The patient was later discharged to a skilled nursing facility (snf) on (b)(6) 2021.Additional information regarding event and patient details have been requested, but are currently unavailable.

Event Description

Additional information was provided on 22feb2021.The customer indicated that the patient's hospitalization was prolonged "potentially 1-2 weeks" due to the event.The patient also required antibiotics due to a diagnosis of methicillin-resistant staphylococcus aureus (mrsa) in the pleural space.

Manufacturer Narrative

Additional information: b2, b5, h6 - patient code.H6 - patient code: no code available (3191) - the patient experienced prolonged hospitalization and required antibiotics for methicillin-resistant staphylococcus aureus (mrsa) as a result of the event.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Manufacturer Narrative

Investigation ¿ evaluation: (b)(6) reported to cook that a thal-quick chest tube set catheter separated at the junction of the funnel connector a few days after placement while getting out of bed.Further communication with the user facility clarified that as a result of this incident, the patient was hospitalized for 1-2 weeks and required vats.Antibiotics in the pleural space were administered for methicillin-resistant staphylococcus aureus (mrsa).The patient was ultimately discharged to a skilled nursing facility.A review of the documentation including the instructions for use (ifu) and quality control procedures, as well as a functional test and visual inspection of the returned device was conducted during the investigation.One thal-quick chest tube was returned to the manufacturer for evaluation.Upon visual inspection, the adapter/funnel was found to be separated from the tubing.No visible damage was noted to the device.The proximal end of the tubing was smooth and slid into the adapter/funnel but did not remain connected.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure prior to distribution.The device's design history files (dhf) were reviewed, and the risks associated with these devices are acceptable when weighed against the benefits.A review of the device history record (dhr) could not be completed due to the lack of lot information from the facility.As there are adequate inspection activities established and objective evidence that the dhr was fully executed, it was concluded that there is no evidence that nonconforming product exists in house or in field.There is no evidence to indicate the device was manufactured out of specification.The product ifu, c_t_thal_rev11] ¿thal-quick chest tube sets and trays,¿ provides the following information to the user related to the reported failure mode: instructions for use ¿9.With the wire guide still positioned within the pleural space, advance the chest tub inserter/chest tube assembly over the wire guide and into the pleural space.10.Remove the wire guide and chest tube inserter, leaving the chest tube in place.11.The chest tube can now be sutured to the skin and is ready for use.¿ based on the information provided, examination of the returned product and the results of our investigation, it was concluded that a component failure unrelated to manufacturing or design deficiencies contributed to the reported failure mode.The appropriate personnel have been notified.Per the risk assessment no further action is required.We will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.

• Brand Name: THAL-QUICK CHEST TUBE SET
• Type of Device: GBX CATHETER, IRRIGATION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 11314386
• MDR Text Key: 231389454
• Report Number: 1820334-2021-00312
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 01/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-TQTS-2000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male