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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for evaluation, however, investigation is not yet complete.
Event or Problem Description
The event involved a monitoring kit w/tp4, 30 ml squeeze flush and needleless valve in which the customer reported that the nurse was hanging new fluids for the patient's arterial line, and when the nurse hooked up the new fluids to the patient, the nurse noticed blood backing up in the line.Upon further inspection it was noticed that the tubing was broken at the tubing/luer connection.Once the nurse noticed blood backing up, the stop cock closest to the infant was immediately turned off to baby and the practitioner was called.The new line was hung and working properly at this time.The customer reported that the product was not reprocessed nor re-sterilized prior to use and that is is not contaminated or contain biohazard or chemotherapeutic agent.There was patient involvement, however, no harm was reported as a consequence of this event.
Additional Manufacturer Narrative
One used device was received for evaluation.The reported complaint of separation was confirmed on the returned set.During visual inspection, the 28" pressure tubing was received separated from the female 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.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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17595579
• Report Number: 9617594-2023-00579
• Device Sequence Number: 7570152
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2023

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: 08/07/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2023
• Supplement Date Received by Manufacturer: 09/05/2023
• Initial Report FDA Received Date: 08/22/2023
• Supplement Report FDA Received Date: 09/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2022
• 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: UNSPECIFIED ADMINISTRATION SET, MFR UNK.; UNSPECIFIED SOLUTION, MFR UNK.
• Patient Sex: Unknown