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

Model Number N/A

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Patient Involvement (2645)

Event Date 04/04/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6.Occupation: unknown.Pma/510(k) #: exempt 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, during an inspection, the primary packaging of the thal-quick chest tube set was observed to be damaged.Two little holes were found in the back of the package.No patient contact was made.

Manufacturer Narrative

Investigation ¿ evaluation a review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, quality control, and specifications of the device, as well as an imaging review, were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, an imaging review was conducted for the pictures provided of the device packaging.The images confirmed two small holes along the seal, confirming the complaint.Additionally, a document based investigation evaluation was performed.Sufficient inspection activities have been established to identify this failure mode prior to distribution.A review of the device history record found no related nonconformances.A review of complaint reporting software found no other reported complaints for this lot.Compiling this information, there is no evidence that nonconforming product exists in house or in field.Based on the information provided, no returned product and the results of the investigation, a definitive cause could not be established.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.Cook 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 the patient and/or event 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
• MDR Report Key: 8680291
• MDR Text Key: 147385001
• Report Number: 1820334-2019-01371
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 00827002041370
• UDI-Public: (01)00827002041370(17)210515(10)8885795
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/15/2021
• Device Model Number: N/A
• Device Catalogue Number: C-TQTS-2400
• Device Lot Number: 8885795
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1