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

Model Number	G06348
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Pneumothorax (2012); Insufficient Information (4580)
Date of Event	03/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer (person): postal code: (b)(6).Occupation: lead tech.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 tube of a thal-quick abscess drainage set broke.This is the first reported event for this patient.The second event is also reported under patient identifier (b)(6).
Event or Problem Description
Additional information was received on 31mar2021.The device was placed for "ascites or fluid".No force was exerted on the catheter.A competitor device was attached to the chest tube.The inpatient experienced prolonged hospital stay due to complications as a result of the event.They also developed a pneumothorax as "air was sucked into the lungs" and required device removal and replacement using the device reported under mdr ref.# 1820334-2021-00932.The device was said to have separated at the "fixed position".
Additional Manufacturer Narrative
A2: date of birth: 1966.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
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Description of event: it was reported that the tube of a thal-quick abscess drainage set broke.The device was placed for "ascites or fluid".No force was exerted on the catheter.A competitor device was attached to the chest tube.The inpatient experienced prolonged hospital stay due to complications as a result of the event.They also developed a pneumothorax as "air was sucked into the lungs" and required device removal and replacement using the device reported under mdr ref.# 1820334-2021-00932.The device was said to have separated at the "fixed position".Investigation ¿ evaluation: a document based investigation was performed including a review of complaint history, device history record, the instructions for use, quality control procedures, as well as a supplier investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.There is no evidence to suggest the product was made out of specification.The investigation found that the affected component is supplied to cook by an external supplier.A supplier investigation was requested.The supplier reviewed manufacturing procedures and the component device history record and concluded that there are no indications that the product manufactured by the supplier failed to meet current specifications.A review of the device history record found no non-conformances related to the reported failure mode.A data base search revealed one additional complaint for lot# 13376422 from the field.The additional complaint on the lot was reported by the same user/customer and for the same issue (reported under medwatch report #:1820334-2021-00932).The chest drain/tube is a supplied component from cook polymer technology (cpt), their investigation concluded that there are no indications that the product manufactured failed to meet specifications and a root cause cannot be determined.Therefore, it was concluded that there is no evidence that nonconforming product exists in house or in field and no further action will be taken at this time.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: instructions for use ¿9.To prepare the drainage catheter assembly for insertion, fully advance the coaxial catheter inserter into the drainage catheter until its hub is locked into position.10.Advance the drainage catheter/inserter assembly over the wire guide and into the abscess cavity.Note: to facilitate introduction, rotate the drainage catheter/inserter assembly during advancement over the wire guide.11.Remove the catheter inserter and wire guide.12.Aspirate abscess cavity contents through the drainage catheter.¿ a review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.Based on the information provided and the results of the investigation, a definitive cause could not be established/determined.Per the quality engineering risk assessment, no further action is warranted.Cook will continue to monitor this device via the complaints database for similar complaints.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
There is no new patient or event information to report.

• Brand Name: THAL-QUICK ABSCESS DRAINAGE 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: 11475555
• Report Number: 1820334-2021-00931
• Device Sequence Number: 14320621
• Product Code: GBX
• UDI-Device Identifier: 00827002063488
• UDI-Public: (01)00827002063488(17)230923(10)13376422
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/23/2023
• Device Model Number: G06348
• Device Catalogue Number: TQAS-2400-J
• Device Lot Number: 13376422
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 03/09/2021
• Supplement Date Received by Manufacturer: 03/31/2021; 01/07/2022
• Initial Report FDA Received Date: 03/12/2021
• Supplement Report FDA Received Date: 04/22/2021; 01/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PLEUR-VAC (ATRIUM BOX)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Weight: 50 KG