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

Model Number N/A

Device Problem Human-Device Interface Problem (2949)

Patient Problem Respiratory Insufficiency (4462)

Event Date 01/03/2022

Event Type  Injury  

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 286526982
• Report Number: 1820334-2022-00105
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 00827002557239
• UDI-Public: (01)00827002557239(17)241118(10)14362272
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 01/14/2022
• Initial Date FDA Received: 01/24/2022
• Supplement Dates Manufacturer Received: 03/22/2022
• Supplement Dates FDA Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 4 DA