MAUDE Adverse Event Report: ICU MEDICAL, INC. MEDEX; PRESSURE MONITORNG TUBING

Catalog Number	MX560
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One device was received for evaluation.As received a crack and crazing was observed on the female luer of the set.In attempts to replicate clinical use the female end of the set was capped and water was pushed through the set using an icu medical provided syringe.A leak was observed the previously observed crack.The complaint of crack can be confirmed.The probable cause of the crazing observed on the luer is due to environmental stress.B3 - date of event - unknown.D4 - lot number - unknown.G4 - pma/510(k) - unknown.
Event or Problem Description
It was stated that the iv extension piece cracked, and blood backed up in the line.Patient was affected.The line had been running tpn and lipids for about 12 hours before it cracked.There was no harm to the patient, and they contacted the responsible person.No monitoring was required.The event was resolved.The patient was a 5-month-old white/caucasian.

• Brand Name: MEDEX
• Common Device Name: PRESSURE MONITORNG TUBING
• Manufacturer (Section D): ICU MEDICAL, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: reed covert ; 6250 shier rings road; dublin, OH 43016 ; 2247062300
• MDR Report Key: 24830336
• Report Number: 1526863-2026-00089
• Device Sequence Number: 13051162
• Product Code: FPA
• UDI-Device Identifier: 10351688506597
• UDI-Public: (01)10351688506597
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/09/2026

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 Catalogue Number: MX560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown
• Patient Race: White