MAUDE Adverse Event Report: ICU MEDICAL, INC MEDEX CLEAR CUFF PRESSURE INFUSION; INFUSOR, PRESSURE, FOR I.V. BAGS

Catalog Number	MX4810
Medical Device Problem Codes	Fluid/Blood Leak (1250); Inflation Problem (1310); Material Separation (1562); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2025
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 reportable information becomes available.
Event or Problem Description
It was reported that there was air leakage from the connecting line with the inflation bulb.The event occurred during pre-test, and it happened at the hospital.There was no patient harm or adverse events reported as a result of the event.
Additional Manufacturer Narrative
D3: mfg establishment name: icu medical, inc.D9: date returned to mfg: 3/26/2025.Device evaluation: one device was received for device analysis.Service history review identified the complaint was not related to a previous service of the device within the review period.Functional testing and visual inspection performed during analysis.The customer reported complaint was confirmed.It was found that the seal was coming apart.Manufacturing process of solvent bonding of tubing to luer connection caused the reported problem of leaking.

• Brand Name: MEDEX CLEAR CUFF PRESSURE INFUSION
• Common Device Name: INFUSOR, PRESSURE, FOR I.V. BAGS
• Manufacturer (Section D): ICU MEDICAL, INC; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21658030
• Report Number: 1526863-2025-00025
• Device Sequence Number: 8271926
• Product Code: KZD
• UDI-Device Identifier: 50351688507004
• UDI-Public: (01)50351688507004(17)320809(10)4318283
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2025

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: MX4810
• Device Lot Number: 4318283
• 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: 02/24/2025
• Supplement Date Received by Manufacturer: 05/31/2025
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2022
• 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