MAUDE Adverse Event Report: COOK INC FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET; GBX CATHETER, IRRIGATION

Model Number	N/A
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Respiratory Insufficiency (4462)
Date of Event	01/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer (person): line 2: direct supplies/ medical devices, phone: (b)(6).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
During the neonatal resuscitation of the patient for the treatment of a recurrent pneumothorax, the care team noted that the three way stop cock attached to the cook fuhrman pleural pneumopericardial drainage catheter was closed.The three way stopcock was to be in the open" position.Needle exsufflation was preformed as a result of the three way stopcock being in the closed position.The care team at the facility noted that the three way stopcock provided for use in the cook fuhrman pleural/pneumopericardial drainage set does not look like the usual 3 way taps used by the team.The cook fuhrman pleural/pneumopericardial drainage remains inserted in the patient's thorax.
Additional Manufacturer Narrative
Correction: weight: 260 grams or 0.26 kg.Investigation ¿ evaluation: c.H.R.U de lille (france) contacted cook stating that the drain stopcock valve was closed and not opened as it is supposed to be.The three-way stopcock was from a c-ppd-850-imh from lot# 14362272.The procedure was for drainage of recurrent pneumothorax for a premature infant.The patient did require an additional procedure, a "needle exsufflation".Cook became aware of this event on (b)(6) 2022.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, the customer did provide photographs to aid in the investigation.The photographs show the referenced cook stopcock, and a sample photo of another manufacturer's stopcock.The cook stopcock matches the cook device drawing.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.A review of the design history file (dhf) showed that this device is both safe and effective for its intended use.A review of the dhr for the reported complaint device lot (14362272) and the related subassembly lot revealed no recorded non-conformances relevant to the failure mode.A database search did not identify any other events associated with the reported device lot.Based on the available information, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in field.Cook also reviewed product labeling.This product is supplied with an instructions for use (ifu) pamphlet c_t_ppd_rev4.In the how supplied section it states: upon removal from package, inspect to ensure no damage has occurred.There are no instructions for use for the three-way stopcock which is supplied with this product.Based on the available information, no product returned, and the results of the investigation, cook has determined that there is no device failure.It was reported that the customer typically uses a different type of stopcock with 3 directional levers; the customer was not familiar with the three-way stopcock provided with this set.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: FUHRMAN PLEURAL/PNEUMOPERICARDIAL 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: 13335177
• Report Number: 1820334-2022-00105
• Device Sequence Number: 20089466
• Product Code: GBX
• UDI-Device Identifier: 00827002557239
• UDI-Public: (01)00827002557239(17)241118(10)14362272
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/18/2024
• Device Model Number: N/A
• Device Catalogue Number: C-PPD-850-IMH
• Device Lot Number: 14362272
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/14/2022
• Supplement Date Received by Manufacturer: 03/22/2022
• Initial Report FDA Received Date: 01/24/2022
• Supplement Report FDA Received Date: 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 4 DA
• Patient Sex: Unknown