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

Model Number	SU130-1311
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that during removal, the fenestrated portion of the drain placed in the lower back, lumbar region, broke off inside of the patient.Patient was taken to the operating room to remove fenestrated drain portion.Broken piece was retrieved.Patient is now otherwise doing well.The surgeon stated the product malfunctioned and it was not user error.
Additional Manufacturer Narrative
An investigation is currently in progress.A follow-up report will be filed once the results have been completed.
Additional Manufacturer Narrative
A non-conformance review was conducted for lot 1241167 and there were no non-conformances related to the reported event issued during the manufacturing of this lot.The lot was manufactured on 09/16/24.Visual inspection and pull test were conducted on drains within this lot and met the established criteria.No manufacturing issues were recorded that could correlate with condition reported.A portion of the used drain was returned for evaluation.A jagged edge at the fracture of the round tubing area and a slash cut in the perforated area was observed.In the area of the fracture, there is a mark on the tubing 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 of 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 which could have damaged the product thus leading to tubing breakage.Currently, a corrective and preventive action has been initiated to further investigate the tube split condition.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: 24562962
• Report Number: 1423537-2026-00061
• Device Sequence Number: 9466743
• Product Code: GBX
• UDI-Device Identifier: 10192253022377
• UDI-Public: (01)10192253022377(17)290930(10)1241167
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2026

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: SU130-1311
• Device Catalogue Number: SU130-1311
• Device Lot Number: 1241167
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2024
• 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: Other; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 73 KG