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

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/19/2022

Event Type  malfunction  

Manufacturer Narrative

Occupation: unknown.Pma/510(k) #: exempt.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported that the catheter included in the thal-quick chest tube set separated from the hub.The chest tube had been in place for drainage for seven days.A daily dressing change was conducted in endoscopy.Upon return from the ward following the last dressing change, it was discovered that the catheter was disconnected at the hub.The endoscopy nurse was called and the drain was closed and then removed after one day.The patent did not experience any adverse effects due to this occurrence.Additional information regarding event details has been requested, but is currently unavailable.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.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.

Event Description

In additional information received on 27jan2022, it was reported that a digital drainage system was connected to the drainage tube at time of failure.The device was secured to the patient with a holding suture.Patient activity level was described as "low,", about 80% bed ridden.The device was not replaced after removal.It was reported "the incident had no influence on the patient's result.".

Event Description

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

Manufacturer Narrative

Correction: h6 - annex f.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.

Event Description

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

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged or unavailable.Investigation/ evaluation: theresien krankenhaus und in germany informed cook of an issue with a thal-quick chest tube set (rpn: c-tqts-2400, lot 13695771).The customer stated the tube was already placed in the patient when the adapter broke off.The drain was closed and removed after one day.The device was not replaced.No adverse effects were experienced by the patient.Reviews of the documentation including the complaint history, device history record, instructions for use (ifu) and quality control procedures of the device, were conducted during the investigation.The complaint device was not returned for evaluation; therefore, no physical examination could be conducted.A photo of the complaint device provided by the customer showed the hub separated from the chest tube.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 mode prior to distribution.A review of the device history record (dhr) for lot 13695771, as well as component and subassembly lots, found no relevant nonconformances that could have contributed to the reported failure mode.The affected components are supplied to cook by an external supplier.Cook requested that the supplier complete an investigation for relevant chest tube raw material lots.The supplier performed visual, dimensional and tensile testing on a sampling basis to evaluate the product.A review of the dhr for each affected lot found no relevant nonconformances.Photos of the complaint device were reviewed by the supplier, and it was stated that the device is similar to the appearance of the product after tensile testing.It appears that the device was subjected to a tensile (pulling) load greater than the bond between the molded hub and extruded tube could withstand.The supplier stated there aren¿t any indications that the product failed to meet specifications.A tensile load was applied to the device resulting in the separation.Cook also reviewed product labeling.The product ifu, [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 -prepare the chest tube insertion site with antiseptic solution and drape in a standard fashion.Note: a mid axial-approach is necessary.-after injection of local anesthetic, make a small skin incision slightly larger than the diameter of the chest tube.-attach the introducer needle to a syringe filled with local anesthetic (e.G., lidocaine), and administer additional local anesthetic to the skin and underlying tissues.-advance the introducer needle over the superior border of the rib and into the pleural space.Fluid or air should be aspirated to verify an intrapleural position.Warning: over insertion of the needle and/or dilators may result in serious harm to the patient.Note: the needle should be introduced and directed with appropriate orientation inferiorly or superiorly.-when the appropriate drainage site has been identified, advance the soft ¿j¿ end of the wire guide through the needle and into the pleural space.Note: the wire guide should pass through the needle and advance into the pleural space without resistance.Note: the skin level marker on the distal end of the wire guide can be used as an insertion depth maker on patients with normal anatomy.Note: due to anatomical variations in chest wall thickness, insertion depth of introducer needle, wire guide and dilators will vary from patient to patient.-remove the needle, leaving the wire guide in place.-liberally inject additional local anesthetic into the intercostal muscles surrounding the wire guide.-while maintaining the wire guide position, dilate the tract and opening into the pleural space by advancing, in sequence small to large, the supplied dilators over the wire guide.Introduction into the pleural space is facilitated by rotating and advancing the dilators in line with the wire guide to prevent kinking.Warning: over insertion of the needle and/or dilators may result in serious harm to the patient.Note: it is important to have enough length of wire guide exiting the access site to facilitate controlled introduction of the dilators.The dilators only have to enter the pleural space to their full diameter and should never be advanced beyond the distal end of the wire guide.-with the wire guide still positioned within the pleural space, advance the chest tube inserter/chest tube assembly over the wire guide and into the pleural space.Note: if resistance is encountered during chest tube assembly insertion, determine the cause of resistance and take necessary action to relieve resistance before proceeding.Note: it is important to advance the chest tube assembly into the pleural space in the same line as the wire guide.This will make introduction easier and avoid kinking of the wire guide.Note: the distal end of the chest tube inserter should not be advanced beyond the distal end of the wire guide.-remove the wire guide and chest tube inserter, leaving the chest tube in place.Note: it is important that all sideports of the chest tube are positioned within the pleural space.-the chest tube can now be sutured to the skin and is ready for use.How supplied supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ evidence provided by the dmr, dhr, and supplier investigation showed no indication the complaint device was manufactured out of specification.There is no evidence of nonconforming material in house or in the field.Based on the supplier¿s evaluation, it appears that the device was subjected to a tensile load greater than the bond between the molded hub and the extruded hub could withstand.There is no evidence of manufacturing deficiency.Based on the information provided, examination of product photos provided by the customer and the results of our investigation, the cause was traced to a component failure.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.

• 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: 13342339
• MDR Text Key: 284824838
• Report Number: 1820334-2022-00110
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 00827002041370
• UDI-Public: (01)00827002041370(17)240118(10)13695771
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/18/2024
• Device Model Number: N/A
• Device Catalogue Number: C-TQTS-2400
• Device Lot Number: 13695771
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2021
• 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
• Treatment: ATMOS S 201 THORAX
• Patient Sex: Female