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	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4 and h4 the lot# was not provided, expiration date, and manufacture date are unknown.The investigation is pending completion.Upon completion a supplemental mdr will be submitted.
Event or Problem Description
A complaint was received regarding a monitoring kit w/tp4, 30 ml squeeze flush and needleless valve that experienced separation during use.The reporter stated that while flushing uac after obtaining labs part of the transducer tubing dislodged from connection site at stopcock.Scrubbed stopcockx3 with chlorhexidine swab and placed a 3ml syringe at the end.Ordered new fluids and called pharmacy to have them sent stat.Entire line changed.There was patient involvement and no adverse event/harm.
Additional Manufacturer Narrative
The following was provided by the customer for complaint investigation: -one used list #42598-01, monitoring kit w/tp4, 30 ml squeeze flush and needleless valve; lot #unknown the reported complaint of tubing separation was confirmed on the returned set.During visual inspection, the 18" pressure tubing was received separated from the male luer.When the end of the tubing was microscopically examined, insufficient adhesive coverage was observed on the tubing pocket.The probable cause of insufficient adhesive coverage on the pressure tubing had occurred due to an error during the assembly process of manufacturing.A device history record review lot could not be conducted because no lot number was identified.Corrected information can be found in concomitant products, e4 and h6 health effect - impact code.

• 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: 21921752
• Report Number: 9617594-2025-00851
• Device Sequence Number: 21087951
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2025

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2025
• Supplement Date Received by Manufacturer: 05/06/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 06/03/2025
• 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: 3ML SYRINGE, MFR UNK.; CHLORHEXIDINE SWAB, MFR UNK.; UMBILICAL ARTERY CATHETER (UAC), MFR UNK.; UNSPECIFIED FLUIDS/INFUSATE, MFR UNK.
• Patient Sex: Unknown