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	08/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.
Event or Problem Description
The event involved a the event involved a tp4 kit w/10cc safeset reservoir, needleless valve, filter millex and admin set.It was reported that when hanging aline tubing, it was connected to patient and was not able to flush line, and blood started to backflow into the line.There was patient involvement and no patient harm reported.The set-up was replaced and therapy was resumed.There were no interventions needed related to blood loss.
Additional Manufacturer Narrative
The reported complaint of not able to flush was confirmed on the returned set.An image was provided by the customer showing the involved device.No visual anomalies were observed on the returned device.When the returned device was primed and pressure leak tested the set was not able to be primed from the millex filter.The rest of the set performed per the specifications.When the millex filter was microscopically examined, the female luer connected to the millex filter was occluded with solvent.The probable cause of the occlusion on the female luer had occurred due to an error during assembly at ensenada.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• 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: 18098020
• Report Number: 9617594-2023-00956
• Device Sequence Number: 7718004
• Product Code: DRS
• UDI-Device Identifier: 00887709050846
• UDI-Public: (01)00887709050846(17)260201(10)13551364
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2023

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: 02/01/2026
• Device Catalogue Number: 46104-65
• Device Lot Number: 13551364
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2023
• Supplement Date Received by Manufacturer: 11/22/2023
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 12/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2023
• 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