MAUDE Adverse Event Report: ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V TRAY, P.A.S. PORT ELITE; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	4591
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Extravasation (1842); Pain (1994); Swelling/ Edema (4577)
Date of Event	11/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional information becomes available.
Event or Problem Description
It was reported that during use of an implanted vascular access device, a malfunction occurred at the connection between the catheter and the port, resulting in leakage of infused fluid into surrounding tissue.This event was reported as an adverse event and involved a patient.The patient experienced pain and swelling, and a second procedure was required to remove and replace the device.During the affected session, only saline was being administered, and no chemotherapy drugs were infused.The patient remained stable, and no permanent injury or patient harm was reported.A new device was implanted without difficulty, and the patient is currently in good condition.
Additional Manufacturer Narrative
No product samples were received for investigation.One (1) customer image was returned showing an open surgery scene where the catheter and port were implanted.The catheter appears to be separated/detached from the port barb.The catheter lock is also present.The complaint of disconnection can be confirmed.The probable cause is unknown.Without the return of the used sample, a comprehensive failure investigation cannot be performed, and a cause cannot be determined.The lot history was reviewed; no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: TRAY, P.A.S. PORT ELITE
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24169056
• Report Number: 3012307300-2026-00538
• Device Sequence Number: 9111255
• Product Code: LJT
• UDI-Device Identifier: 10610586021565
• UDI-Public: (01)10610586021565(17)280105(10)6023288
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K961580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 4591
• Device Catalogue Number: 21-4591-24
• Device Lot Number: 6023288
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2026
• Supplement Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/10/2024
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown