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

Model Number	SU130-0323
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/25/2026
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 the drains are breaking off inside the patient.On (b)(6) 2026, patient had an initial surgery for nerve monitored left l4 hemilaminectomy with navigation and fusion l4-5.On (b)(6) 2026, nursing notes stated that some resistance was met on drain removal, however, jp drain tip not intact.The nurse was unable to see the tip in view.On (b)(6) 2026, the patient was brought back to surgery for removal of the jp drain tip from the back.Specimen sent to the hospital lab.No further information was provided.
Additional Manufacturer Narrative
A non-conformance/device history record review for the reported lot number was conducted.Lot 1240157 was manufactured on 02/20/24.Visual inspection and pull test were conducted on the drains within this lot.All in-process and final acceptance inspections were performed in accordance with established procedures.Inspection results were within acceptable limits, and no manufacturing or inspection anomalies related to the reported issue were identified.Two devices were received for evaluation and underwent visual and microscopic inspection.Both devices showed a jagged edge at the fracture of the round tubing.For both, there is a mark around the tubing fracture that suggests that an instrument was used to handle the product.Per the instructions for use (ifu), drains or tubing should not be handled with any instruments.This can lead to tearing, warping or weakening and subsequent breakage of the drain.Also to facilitate removal of the drain, the drain and tubing portions should not be curled, pinched, over-stretched or sutured; either internally or externally.Do not suture the drain(s).The most probable root cause was identified as user error, not following ifu, since the mark at the jagged edge at the fracture area suggests that an instrument was used to handle the product in which could have damaged the product thus leading to tubing breakage.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 JACKSON PRATT
• 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: 24653286
• Report Number: 1423537-2026-00076
• Device Sequence Number: 6013018
• Product Code: GBX
• UDI-Device Identifier: 10192253022247
• UDI-Public: (01)10192253022247(17)290228(10)1240157
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2026

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: SU130-0323
• Device Catalogue Number: SU130-0323
• Device Lot Number: 1240157
• 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: 02/26/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2024
• 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; Other
• Patient Sex: Unknown