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

Model Number	SU130-0321
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Hematoma (1884); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer reported that on the evening of day of surgery for a revision hemilaminectomy l2-3 right (back), the patient was bleeding heavily from the surgical site into and around the jp drain.Then the patient suddenly had minimal drainage output.Dr.Ordered stripping drain tubing.When this was done the tubing snapped easily with minimal pressure to tubing.This then required a return to the operating room.Under anesthesia, a hematoma was evacuated, the wound was washed out, and two new surgical drains were placed.The patient fully recovered.
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
Lot 1250349 was manufactured on 04/14/25.Visual inspection and pull test were conducted on the drains within this lot and and the drains passed the established acceptance criteria.A sample was received for investigation.Visual and microscopic inspection was conducted and breakage in the non-perforated area was observed.No manufacturing issues were identified for this work order.There was no evidence of excessive force or abnormal handling observed on the returned sample.The root cause cannot be determined.We will continue to monitor related reports to determine if additional actions are necessary.
Additional Manufacturer Narrative
Correction report being filed against mdr 1423537-2025-00416, follow-up 1.H1 had been inadvertently marked as malfunction.H1 has been corrected to a serious injury.No other changes to the report are required.

• 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: 23330889
• Report Number: 1423537-2025-00416
• Device Sequence Number: 20896264
• Product Code: GBX
• UDI-Device Identifier: 10192253022230
• UDI-Public: (01)10192253022230(10)1250349
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/24/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: SU130-0321
• Device Catalogue Number: SU130-0321
• Device Lot Number: 1250349
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 12/23/2025; 12/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2025
• 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; Other
• Patient Age: 63 YR
• Patient Sex: Male