MAUDE Adverse Event Report: ICU MEDICAL, INC MEDEX SINGLE LINE PRESSURE MONITORING KIT; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number	MX9604A
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the connector was broken, causing blood leakage.The reported event occurred during a treatment at the operation room.The event occurred during patient use, however, no harm was reported.
Additional Manufacturer Narrative
H3: no product was received for analysis.The device history record of reported lot 4137545 was reviewed and it was confirmed that no non-conformities were reported during production.The quality inspection forms were reviewed, and it was observed that no defects were found, and the lot was released.Without the return of the product a comprehensive failure investigation cannot be performed, and a probable cause cannot be determined.If the product is returned, the manufacturer will reopen this complaint for further investigation.
Additional Manufacturer Narrative
D3: mfg establishment name; icu medical, inc device evaluation: no product returned for device analysis; a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No product was returned; therefore, no visual and functional tests were performed, the reported complaint could not be confirmed, and the root cause could not be determined.If the product is returned, the manufacturer will reopen this complaint for further investigation.

• Brand Name: MEDEX SINGLE LINE PRESSURE MONITORING KIT
• Common Device Name: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL, INC; carretera miguel alemán km21.7; apodaca nuevo leon ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22872468
• Report Number: 1526863-2025-00099
• Device Sequence Number: 21405125
• Product Code: DRS
• UDI-Device Identifier: 10351688502933
• UDI-Public: (01)10351688502933(17)240419(10)4137545
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K820355
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2025

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 Expiration Date: 04/19/2024
• Device Catalogue Number: MX9604A
• Device Lot Number: 4137545
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/20/2021
• 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