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	46104-07
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a monitoring kit w/tp4, 30 ml squeeze flush, and needleless valve was found broken within minutes of attaching the new line to the patient's umbilical artery catheter (uac), and the registered nurse (rn) noticed backflow of blood through uac.Immediately noted that the tubing had broken on the distal side of the blood draw port.Uac was immediately clamped.The broken transducer was disconnected and uac flushed with normal saline.New tubing was primed and attached to the patient's uac.The broken transducer was bagged and kept in the c4b clinical leader's office.To note, this is a c4b patient currently on h4b for extracorporeal membrane oxygenation (ecmo).C4b charge rn and ecmo tech notified of equipment issue.There was no medication being used with the product and the product was not reprocessed or re-sterilized prior to use.There was no patient harm reported.
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.
Additional Manufacturer Narrative
The reported complaint of leakage was confirmed on the returned set.During visual inspection, the 28" pressure tubing was received separated from the male luer.Insufficient adhesive coverage was observed on the tubing pocket.The separation of the bond was due to insufficient adhesive coverage on the pressure tubing.The probable cause of insufficient adhesive coverage on the pressure tubing had occurred due to an error during assembly at ensenada.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• 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: 17831485
• Report Number: 9617594-2023-00763
• Device Sequence Number: 19671181
• Product Code: DRS
• UDI-Device Identifier: 00887709060623
• UDI-Public: (01)00887709060623(17)251101(10)11376856
• 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): 08/28/2023

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: 11/01/2025
• Device Catalogue Number: 46104-07
• Device Lot Number: 11376856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2023
• Supplement Date Received by Manufacturer: 10/17/2023
• Initial Report FDA Received Date: 09/28/2023
• Supplement Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2022
• 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: UMBILICAL ARTERY CATHETER (UAC)
• Patient Sex: Unknown