MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TP4 KIT W/10CC SAFESET RESERVOIR, NEEDLELESS VALVE, FILTER MILLEX AND ADMIN SET; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number	46104-65
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for evaluation.Investigation is pending.D4: only di provided as lot number is unknown.
Event or Problem Description
The event involved a tp4 kit w/10cc safeset reservoir, needleless valve filter millex and admin set where it was reported the registered nurse (rn) drew labs from the a-line without issue; however, when he attempted to flush the line, he was unable to pull any flush from the bag.The a-line still had a good waveform and blood return.The line was changed out and the old line was placed.There is potential patient harm with extra line change at risk for clabsi.There were no other devices being used on the patient at the time of the event.There was patient involvement and unknown patient harm.
Additional Manufacturer Narrative
The reported complaint of no flow was confirmed.No visual anomalies were observed on the returned set.When the returned set was primed and pressure leak tested, the admin set was unable to be primed through the millex filter.The rest of the set was able to be primed and no leaks were observed.It is unknown why the millex filter was unable to be primed.The probable cause of the millex filter unable to be primed could not be determined.Lot history review could not be conducted because no lot number(s) was/were identified.

• Brand Name: TP4 KIT W/10CC SAFESET RESERVOIR, NEEDLELESS VALVE, FILTER MILLEX AND ADMIN SET
• 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: 21859446
• Report Number: 9617594-2025-00784
• Device Sequence Number: 4684596
• Product Code: DRS
• UDI-Device Identifier: 00887709050846
• UDI-Public: 00887709050846
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 06/16/2025

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: 46104-65
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2025
• Supplement Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 06/16/2025
• 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
• Patient Age: 4 YR
• Patient Sex: Male