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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter in a fuhrman pleural/pneumopericardial drainage set separated.The device was required by an unknown patient for use as a chest drain.A "few" days after device placement, during routine examination, the catheter was found separated from the hub.The separated portion was "on the edge" of the hub.The device was then removed but not replaced.A chest x-ray was performed to confirm that no part of the device remained in patient.It was noted that prior to failure the catheter was attached to a closed suction circuit and that the line was clamped at a point " much further down" than the catheter hub.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
Patient age: infant.Pma/510(k) #: exempt.Country: (b)(6).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Additional Manufacturer Narrative
Patient age: infant.Pma/510(k) #: exempt.Initial reporter - country: (b)(6).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 catheter in a fuhrman pleural/pneumopericardial drainage set separated.The device was required by an unknown patient for use as a chest drain.A "few" days after device placement, during routine examination, the catheter was found separated from the hub.The separated portion was "on the edge" of the hub.The device was then removed but not replaced.A chest x-ray was performed to confirm that no part of the device remained in patient.It was noted that prior to failure the catheter was attached to a closed suction circuit and that the line was clamped at a point " much further down" than the catheter hub.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 unknown, unavailable, or unchanged.Additional information: b5, d9 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.
Event or Problem Description
The device was received by cook on (b)(6) 2022.It was noted that the shaft of the catheter was separated and a small portion of the catheter remained inside the hub.
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: northampton general hospital in the united kingdom stated that during a routine patient examination, the hub separated from the shaft of the catheter.The device was in place for a few days.The device was removed and was not replaced.A chest x-ray was performed to confirm that no part of the catheter remained in the patient after the device was removed.The device was clamped in place further down from the hub where the separation took place.The catheter was from a c-ppd-600-wce-imh set from lot# 10072437.A review of the complaint history, device history record, instructions for use (ifu), and quality control procedures, as well as a visual inspection of the returned product, were conducted during the investigation.The device was returned to cook for evaluation.The catheter separated approximately 2mm below the hub of the device.The catheter inner and outer diameters measured within specification.Additionally, a document based investigation evaluation was performed.A review of the device master record found there are process checks during the manufacturing process to identify non-conforming product and prevent non-conforming product from leaving house.A review of the device history record (dhr) was also conducted as a part of the investigation to check for failure related nonconformances and additional complaints.The dhr for the complaint lot and related subassembly lots found no relevant nonconformances.There are no other complaints on this lot number.There is no evidence on non-conforming material in house or in the field.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.Based on the information provided, the examination of returned product and the results of the investigation, the most likely cause for this failure is component failure.The appropriate internal personnel have been notified.Per the risk assessment, no further action is required.Cook will continue to monitor for similar complaints.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: 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: 13051652
• Report Number: 1820334-2021-02721
• Device Sequence Number: 14431307
• Product Code: GBX
• UDI-Device Identifier: 00827002557147
• UDI-Public: (01)00827002557147(17)221009(10)10072437
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/17/2022

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: 10/09/2022
• Device Model Number: N/A
• Device Catalogue Number: C-PPD-600-WCE-IMH
• Device Lot Number: 10072437
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/13/2021
• Supplement Date Received by Manufacturer: 01/06/2022; 03/16/2022
• Initial Report FDA Received Date: 12/21/2021
• Supplement Report FDA Received Date: 01/11/2022; 03/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2019
• 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