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

Model Number	N/A
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/04/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: GBX CATHETER, IRRIGATION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8680291
• Report Number: 1820334-2019-01371
• Device Sequence Number: 19286603
• Product Code: GBX
• UDI-Device Identifier: 00827002041370
• UDI-Public: (01)00827002041370(17)210515(10)8885795
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2019

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 05/22/2019
• Supplement Date Received by Manufacturer: 07/23/2019
• Initial Report FDA Received Date: 06/07/2019
• Supplement Report FDA Received Date: 07/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1