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

Model Number	N/A
Medical Device Problem Codes	Unsealed Device Packaging (1444); Problem with Sterilization (1596)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.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 or Problem Description
It was reported to cook 13sep2022, that two thal-quick chest tube trays arrived to a user facility in an unsealed state.No patient contact was made with either device.Additional information regarding the event has been requested but is currently unavailable.
Event or Problem Description
Additional information was received on 27sep2022 in regards to date of event and return of devices.The date of event occurred on 12sep2022.Returning of the reported two devices was confirmed.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.B3 - date of event : 12sep2022.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.
Additional Manufacturer Narrative
Correction: the device was received by cook on 04oct2022.The preliminary device failure analysis showed traces of adhesive from the packaging seals; however, the packaging seals are damaged.There is no evidence to suggest that the observed device failure would be likely to cause or contribute to a death or a serious injury if the failure were to recur.Furthermore, there is no evidence that the device caused or contributed to a serious injury, as no life-threatening or permanently impairing injury took place, nor was intervention taken as a result of the device failure which would be required to prevent permanent impairment or damage to the patient.As such, the event is not reportable under fda 21 cfr part 803 as it does not meet the criteria for a death, serious injury, or reportable product malfunction.No further reports regarding this event will be submitted.
Event or Problem Description
This occurrence no longer meets the criteria for a reportable event.See h10.

• Brand Name: THAL-QUICK CHEST TUBE TRAY
• Common Device Name: 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: 15473592
• Report Number: 1820334-2022-01518
• Device Sequence Number: 11525852
• Product Code: GBX
• UDI-Device Identifier: 00827002070905
• UDI-Public: (01)00827002070905(17)240801(10)14840397
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/07/2022

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: Health Professional
• Device Expiration Date: 08/01/2024
• Device Model Number: N/A
• Device Catalogue Number: C-TQTSY-1400
• Device Lot Number: 14840397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/13/2022
• Supplement Date Received by Manufacturer: 09/27/2022; 10/04/2022
• Initial Report FDA Received Date: 09/23/2022
• Supplement Report FDA Received Date: 09/30/2022; 10/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown