MAUDE Adverse Event Report: CARDINAL HEALTH R ANG THOR CATH 24FR; CATHETER AND TIP, SUCTION

Model Number	8888571034
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that the patient had mediastinal drains after heart surgery.Active bleeding was present in the retrocardiac drain and extensive milking with forceps was required.Per customer, the retro cardiac drain was cracked at the joint and was ready to rupture.There was no harm reported.
Additional Manufacturer Narrative
The lot number provided by the customer is not a valid lot number.The device history record review could not be performed.The letter that represents the month is missing on the lot number provided.The manufacturing site has reviewed its lot tracking system and there are no lot manufactured with 22504fhx for this item code.As a part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.Two used samples were returned for the analysis.From the customer¿s reported issue description, the customer refers to ¿a joint¿ but there are no joints on the catheter.Upon further review, it was confirmed that the customer was referring to the blue x ray line in the catheter.A picture was provided for the evaluation.Upon visual analysis, the reported issue was not confirmed through the provided picture.Two used samples were visually inspected at both ends of the catheter to ensure there was no issue.Both samples were then inspected along the blue x-ray line and no issues were found.A cdu croppable stepped connector was then placed into the catheter to ensure that this was not causing the reported issue and again no issues were found, the connector was placed into the catheter and removed.No ¿cracks at the joint¿ were seen.No functional testing could be completed as the samples were used.As a result of the investigation, the reported condition cannot be confirmed.At this time, a corrective and preventive action is not deemed necessary.We will keep monitoring the process for any adverse trends that require immediate attention.This complaint will be used for qa tracking and trending purposes.
Event or Problem Description
The customer reported that the patient had mediastinal drains after heart surgery.Active bleeding was present in the retrocardiac drain and extensive milking with forceps was required.Per customer, the retro cardiac drain was cracked at the joint and was ready to rupture.There was no harm reported.Additional information was received and stated that two devices were used on the same patient on the same incident date, and both had the same issue.Per customer, the ¿at the joint¿ refers to the blue line along the length of the drain.The customer further stated that it was not their practice to add any other piece to the catheter.
Additional Manufacturer Narrative
Section b5 has been updated to include additional information.
Additional Manufacturer Narrative
Section h6 (type of evaluation) originally reported as 3331- analysis of product record.The section should be left blank, as the lot number provided by the customer is not a valid lot number.The device history record review could not be performed.

• Brand Name: R ANG THOR CATH 24FR
• 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: 16336714
• Report Number: 9612030-2023-03544
• Device Sequence Number: 15164753
• Product Code: JOL
• UDI-Device Identifier: 20884521050904
• UDI-Public: 20884521050904
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 03/27/2023

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: 8888571034
• Device Catalogue Number: 8888571034
• Device Lot Number: 22504FHX
• 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: 02/07/2023
• Supplement Date Received by Manufacturer: 02/07/2023; 02/07/2023; 02/07/2023
• Initial Report FDA Received Date: 02/09/2023
• Supplement Report FDA Received Date: 03/09/2023; 03/24/2023; 03/27/2023
• 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
• Patient Sex: Unknown