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

Model Number	8888571059
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the pericardial chest tube noted to be cracked/disconnected after patient reported hearing slurping" sounds.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that the pericardial chest tube noted to be cracked/disconnected after patient reported hearing slurping" sounds.Additional information was received from the customer and stated that the part of the tube that was cracked was the part where the tubing of the canister would attach to the chest tube that is in the patient.There were no pieces left inside the patient.There was no harm noted to the patient due to this issue as the physician assistant came and assessed the patient and told them to remove the chest tube.Per customer, no additional medical intervention was required to remove the tube - it was removed as per policy and procedure.The patient was discharged home.
Additional Manufacturer Narrative
Section g1 (manufacturing site name and address): originally reported as cardinal health, sragh industrial estate, co, tullamore, offaly, ireland, r35 h903 and should be cardinal health, calle 9 sur no.125 cuidad ind, tijuana, mexico, 22500.Section g8 (manufacturer report number): the registration number was originally reported as 1423537 and should be 9612030.
Additional Manufacturer Narrative
The device was provided for evaluation and the reported issue was observed; however, a root cause could not be determined.Since a lot number was not provided, the device history record review could not be performed.Cardinal health will continue to monitor, and all information received will be used for tracking and trending purposes.

• Brand Name: R ANG THOR CATH 32FR
• Common Device Name: CATHETER AND TIP, SUCTION
• Manufacturer (Section D): CARDINAL HEALTH; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 19761868
• Report Number: 1423537-2024-00076
• Device Sequence Number: 8604846
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/21/2024

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
• Device Model Number: 8888571059
• Device Catalogue Number: 8888571059
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 08/22/2024; 09/18/2024; 10/22/2024
• 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
• Patient Sex: Unknown