MAUDE Adverse Event Report: COOK INC WAYNE PNEUMOTHORAX SET; JOL CATHETER AND TIP, SUCTION

Model Number	N/A
Medical Device Problem Codes	Leak/Splash (1354); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2021
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 a (b)(6), female patient required a wayne pneumothorax set for drainage of the left pleura.During the procedure, leakage was found at the joint of the catheter and hub.A photo provided by the customer showed a small hole/tear in the catheter tubing near the hub.A new, similar device was used to complete the procedure successfully.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unchanged, unknown or unavailable.Investigation ¿ evaluation kaohsiung veterans general hospital (taiwan) informed cook that on (b)(6) 2021 the catheter shaft in a wayne pneumothorax catheter set and tray (rpn: c-utpt-1400-wayne-112497, lot# 13844869) was leaking.The product made patient contact before the failure was noticed.The physician changed to a new package to finish the procedure.It was reported that the patient experienced no adverse events due to this occurrence.No unintended section of the device remained in the patient.Reviews of the complaint history, device history record, instructions for use (ifu), and quality control procedures, as well as a visual inspection and functional test of the returned device, were conducted during the investigation.Cook received one used pneumothorax catheter.A visual inspection showed a small hole on the catheter shaft at the hub.A leak test confirmed leaking at the hole.Additionally, a document-based investigation evaluation was performed.In response to this incident, cook completed a review of the product device master record (dmr) and concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook reviewed the device history record (dhr) for lot 13844869 and records no relevant non-conformances.A search on the sub assembly lots ic13661949 and ic13661955 found one non-conformance for surface defect and was detected during the quality control specification.All non-conforming product for the subassembly lot was scrapped.There was one additional final lot containing the sub-assembly lots, and there were no additional complaints or non-conforming product on this additional final lot.A database search for complaints on the reported lot found no additional complaints reported from the field.The production logs from (b)(6) 2021 to (b)(6) 2021 for the assembler were acquired and checked.There were no additional non conformances or complaints reported from the field on the additional lots manufactured by this assembler.Based on the dfa, dmr, and dhr, there is indication the device was manufactured out of specification.There is no evidence of additional nonconforming material in house or in the field.Cook also reviewed product labeling.The product ifu, [c_t_waynemod_rev5] ¿wayne pneumothorax set for seldinger placement,¿ provides the following information to the user related to the reported failure mode: how supplied: ¿-upon removal from package, inspect the product to ensure no damage has occurred." 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 traced to a manufacturing deficiency.The catheter is flared into the hub during the manufacturing process.It was determined that the failure occurred during this flaring process.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.
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: WAYNE PNEUMOTHORAX SET
• Common Device Name: JOL CATHETER AND TIP, SUCTION
• 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: 12728111
• Report Number: 1820334-2021-02427
• Device Sequence Number: 16533630
• Product Code: JOL
• UDI-Device Identifier: 00827002111820
• UDI-Public: (01)00827002111820(17)230216(10)13844869
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2022

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: 02/16/2023
• Device Model Number: N/A
• Device Catalogue Number: C-UTPT-1400-WAYNE-112497
• Device Lot Number: 13844869
• 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: 10/28/2021
• Supplement Date Received by Manufacturer: 07/26/2022
• Initial Report FDA Received Date: 11/01/2021
• Supplement Report FDA Received Date: 08/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2021
• 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: Female
• Patient Weight: 50 KG