MAUDE Adverse Event Report: CARDINAL HEALTH CARDINAL HEALTH; CATHETER, IRRIGATION

Model Number	SU130-1320
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record (dhr) could not be reviewed as no lot information was provided within the complaint.Prior to a lot¿s release, the lot must be deemed acceptable by passing inspections that are based on a valid sampling plan.During production, inspectors routinely examine a statistical sample both physically and visually.There were no samples returned for evaluation; therefore, the affected device could not be evaluated to confirm the reported failure.As such, a root cause could not be determined.We will continue to monitor related reports to determine if additional actions are necessary.
Event or Problem Description
Customer reported that drains were initially removed without any concern in the ent clinic.A 7mm retained piece of jackson pratt drain was noted and removed after discovered intraoperatively during a surgery.The piece was removed endoscopically, removal confirmed by x-ray, and tubing sent to pathology.Ct scan to be given to ensure no further small fragments and if there are, will be able to remove with next surgery.The client and contact information is unknown.

• Brand Name: CARDINAL HEALTH
• Common Device Name: CATHETER, IRRIGATION
• Manufacturer (Section D): CARDINAL HEALTH; 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: 22064325
• Report Number: 1423537-2025-00206
• Device Sequence Number: 7638572
• Product Code: GBX
• UDI-Device Identifier: 10192253022391
• UDI-Public: (01)10192253022391
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/21/2025

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: SU130-1320
• Device Catalogue Number: SU130-1320
• 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: 04/29/2025
• Initial Report FDA Received Date: 05/21/2025
• 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: 9 YR
• Patient Sex: Unknown