MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. MONITORING KIT W/TP4, 30 ML SQUEEZE FLUSH AND NEEDLELESS VALVE; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number	42598-01
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medwatch report (b)(4) received stated that "while flushing uac [umbilical arterial catheter] after obtaining labs part of the transducer tubing dislodged from connection site at stopcock (transducer saved and given to management).Scrubbed stopcock x3 with chlorhexidine swabs and placed a 3ml syringe at the end.Ordered new fluids and called pharmacy to have them sent stat.Entire line changed." this event occurred on an unspecified date in february 2025 in the critical care at the facility.Additional information was provided by the customer on 13-may-2025: the fluid used to flush the tubing was normal saline.The line was changed and new iv therapy had to be ordered and made by pharmacy.There was no medical intervention needed.There are no additional clinical comments or observation regarding these events/products.There was no harmed/adverse event reported.
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.D9 - date returned to mfg: 16apr2025.
Additional Manufacturer Narrative
The reported complaint of separation was confirmed based on the image provided no product samples, videos were returned for investigation.However, an image was provided by the customer showing the pressure tubing separation.Without the return of the reported sample, a probable cause could not be identified.Lot history review could not be conducted because no lot number(s) was/were identified.

• Brand Name: MONITORING KIT W/TP4, 30 ML SQUEEZE FLUSH AND NEEDLELESS VALVE
• Common Device Name: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 22158932
• Report Number: 9617594-2025-01159
• Device Sequence Number: 18310179
• Product Code: DRS
• UDI-Device Identifier: 00887709042582
• UDI-Public: 00887709042582
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K061573
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2025

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: 42598-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2025
• Supplement Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 06/06/2025
• Supplement Report FDA Received Date: 08/01/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NORMAL SALINE, MFR UNK; UNSPECIFIED FLUID/INFUSATE, MFR UNK; UNSPECIFIED UAC LINE, MFR UNK
• Patient Sex: Unknown