MAUDE Adverse Event Report: COOK INC THAL-QUICK CHEST TUBE ADAPTER; KGZ ACCESSORIES, CATHETER

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/21/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

The customer reported that the thal-quick chest tube adapter leaked "at the level of the stopcock under the injection site" (sic).The chest tube set itself was placed in auxiliary access for pleural fluid drainage.The operator was attempting to administer urokinase/nacl and then pulmozyme/nacl.The injection was ultimately performed by taking off the cap on the stopcock and placing a cap on the 1st injection site, which did not leak.Additionally, the customer reported that the instruction for use (ifu) were not shipped with the device, so the operator was not sure if the device was suitable for injection or not.The clinical consequences which resulted from the product issue were reported to be a loss of the patient's medicine as well as a delay of the intended injection.The product is reportedly unavailable for evaluation.

Manufacturer Narrative

The chest tube set was placed in axillary access for pleural fluid drainage.Initial report stated that it was placed in auxiliary access.Investigation - evaluation: a review of the complaint history, drawings, device history record, documentation, manufacturing instructions, specifications, and quality control data was conducted during the investigation.The device in question, photos, operating reports, x-rays, and scans were requested; but the reporter indicated that no such material will be provided.The complaint device was not returned; therefore, no physical examination could be performed.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product, as well as the component device history records, show no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.Based on the information provided, no product returned, and the results of our investigation; a definitive root cause could not be determined.However, appropriate measures have been initiated for this failure mode.We will continue to monitor for similar complaints and have notified the proper personnel about this event.

• Brand Name: THAL-QUICK CHEST TUBE ADAPTER
• Type of Device: KGZ ACCESSORIES, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 7015400
• MDR Text Key: 92741080
• Report Number: 1820334-2017-03794
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 00827002074675
• UDI-Public: (01)00827002074675(17)200901(10)8188676
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-TQF-28.0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2017
• Initial Date FDA Received: 11/09/2017
• Supplement Dates Manufacturer Received: 01/11/2018
• Supplement Dates FDA Received: 01/23/2018
• Date Device Manufactured: 09/01/2017
• 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