MAUDE Adverse Event Report: CARDINAL HEALTH R ANG THOR CATH 32FR; CATHETER AND TIP, SUCTION

Model Number	8888571059
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	06/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
Per customer, the staff surgeon stated that the chest tube caused tamponade and it¿s not safe for cardiac patients.No medical intervention was required, and no intubation was necessary.Additional information was received from the surgeon and stated that the original intended procedure for this patient was coronary angiography.There was no malfunction per se of the chest tube.The staff surgeon further explained that the issue was that the tube in question was much stiffer than their prior products.The event resulted in compression of a bypass graft, and in this event, it was not tamponade.The chest tube was removed as a result and the patient was discharged home.
Additional Manufacturer Narrative
See section b3 for event date provided.Section b5 has been updated to include additional information.
Event or Problem Description
Per customer, the staff surgeon stated that the chest tube caused tamponade and it¿s not safe for cardiac patients.No medical intervention was required, and no intubation was necessary.Additional information was received from the surgeon and stated that the original intended procedure for this patient was coronary angiography.There was no malfunction per se of the chest tube.The staff surgeon further explained that the issue was that the tube in question was much stiffer than their prior products.The event resulted in compression of a bypass graft, and in this event, it was not tamponade.The chest tube was removed as a result and the patient was discharged home.The customer further stated on (b)(6)2023, that the incision was made with a blade and a track was created with a kelly forceps and then the chest tube was inserted in standard fashion.The customer is now using teleflex tubes.
Additional Manufacturer Narrative
Since a lot number was not provided, the device history record review could not be performed.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.Per customer, the defective product was discarded.Based on the information available to us, we were unable to confirm the event.In the meantime, all information received will be used for further tracking and trending purposes.

• Brand Name: R ANG THOR CATH 32FR
• Common Device Name: CATHETER AND TIP, SUCTION
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 17238440
• Report Number: 9612030-2023-03745
• Device Sequence Number: 6969565
• Product Code: JOL
• UDI-Device Identifier: 10884521060937
• UDI-Public: 10884521060937
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/02/2023

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 Model Number: 8888571059
• Device Catalogue Number: 8888571059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2023
• Supplement Date Received by Manufacturer: 06/16/2023; 06/16/2023
• Initial Report FDA Received Date: 06/30/2023
• Supplement Report FDA Received Date: 09/11/2023; 10/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown