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

Model Number	G04137
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2021
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.
Event or Problem Description
It was reported that the packaging of a thal-quick chest tube set was "stained".A photo of the device revealed a small, black foreign matter within the sealed packaging.No patient contact was made, as the device was not used.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unchanged, unknown or unavailable.Investigation ¿ evaluation: chung shan med.Univ.Hosp.(taiwan) informed cook on 15sep2021 that the packaging of a thal-quick chest tube set (rpn: c-tqts-2400) from lot 10096293 had a stain.The user noted the stain prior to opening the device and suspected the quality was compromised, so it was returned to cook.A review of the complaint history, device history record, instructions for use (ifu), and quality control, as well as a visual inspection of the returned device, were conducted during the investigation.One device was received in an unopened, unused condition.There was no stain noted, but there was a small metal flake observed near the seal.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.In response to this incident, cook reviewed the device history record (dhr).The dhr for lot 10096293 records no non-conformances.A database search for complaints on the reported lot found no additional complaints reported from the field.The device's design history files (dhf) were reviewed, and the risks associated with these devices are acceptable when weighed against the benefits.Cook also reviewed product labeling.The product ifu, [c_t_thal_rev10] ¿thal-quick chest tube sets and trays¿ provides the following information to the user related to the reported failure mode: how supplied: ¿sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.¿ the information provided upon review of the dmr, dhr, dhf, ifu, provided imaging, and device examination suggest that there is evidence the device was manufactured out of specification, but that there are no other nonconforming devices in house or out in the field.Based on the information provided, inspection of the returned device, and the results of the investigation, it was determined the cause of this event is related to manufacturing and quality control deficiency.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.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
• 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: 12540708
• Report Number: 1820334-2021-02228
• Device Sequence Number: 1428093
• Product Code: GBX
• UDI-Device Identifier: 00827002041370
• UDI-Public: (01)00827002041370(17)221021(10)10096293
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2022

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
• Device Expiration Date: 10/21/2022
• Device Model Number: G04137
• Device Catalogue Number: C-TQTS-2400
• Device Lot Number: 10096293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/15/2021
• Supplement Date Received by Manufacturer: 06/28/2022
• Initial Report FDA Received Date: 09/28/2021
• Supplement Report FDA Received Date: 07/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2019
• 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