MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CARDINAL HEALTH; CATHETER, IRRIGATION

Model Number	SU130-1320
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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 a silicone round drain, jackson-pratt, 7fr, broke into two pieces post operatively.The existing drain was still used and remaining tubing was reconnected to the bulb.There was no harm to the patient.
Additional Manufacturer Narrative
A non-conformance review was conducted for lot 1241035 and there were no non-conformances related to the reported event issued during the manufacturing of this lot.Visual inspection and pull test were conducted on the drains within this lot and met the established acceptance criteria.There was no device returned for evaluation; therefore, the affected device could not be evaluated to determine the root cause.A corrective and preventive action has been initiated to further investigate the reported issue.We will continue to monitor and take actions, as applicable.

• Brand Name: CARDINAL HEALTH
• 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: 24501561
• Report Number: 1423537-2026-00053
• Device Sequence Number: 16079634
• Product Code: GBX
• UDI-Device Identifier: 10192253022391
• UDI-Public: (01)10192253022391(11)290831(10)1241035
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2026

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
• Operator of Device: Health Professional
• Device Model Number: SU130-1320
• Device Catalogue Number: SU130-1320
• Device Lot Number: 1241035
• 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: 02/10/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2024
• 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 Sex: Unknown