MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC 10FR SILICONE DRAIN WITH TROCAR; CATHETER, IRRIGATION

Model Number	SU130-0321
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation is currently in progress.A follow-up report will be filed once the results have been completed.
Event or Problem Description
Customer reported that a patient had a return to surgery for a fractured jp drain.Per md, "drain tubing broken with retrograde flow of blood and anterograde flow of blood".This resulted in return to the or for evacuation of hematoma and replacement of the drain.
Additional Manufacturer Narrative
As no samples were returned for evaluation, a root cause could not be determined.A review of the device history record for the reported lot number 1250068 was found to have been manufactured and released to predetermined specifications.No anomalies were found during review of the records.Pull testing was conducted on the retained drains within this lot, and all results met the established acceptance criteria.Cardinal health will continue to monitor and trend all similar reported product related issues.

• Brand Name: 10FR SILICONE DRAIN WITH TROCAR
• Common Device Name: CATHETER, IRRIGATION
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): PR006 PUERTO RICO-ANASCO; state rd. 402 , north km 0.9; anasco PR 00610
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 22198741
• Report Number: 1423537-2025-00252
• Device Sequence Number: 8837708
• Product Code: GBX
• UDI-Device Identifier: 10192253022230
• UDI-Public: (01)10192253022230(11)250116(17)300131(10)1250068
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2025

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: SU130-0321
• Device Catalogue Number: SU130-0321
• Device Lot Number: 1250068
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 06/27/2025
• Date Device Manufactured: 01/16/2025
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male