MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. MONITORING KIT W/SAFESET¿ II, 03 ML FLUSH DEVICE & MARVELOUS VALVE; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number 460990471

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/14/2023

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation, however, it has not yet been received.Additional contact telephone number -(b)(6).

Event Description

The event involved a monitoring kit w/safeset¿ ii, 03 ml flush device & marvelous valve where the customer reported that the arterial line disconnected and leaking.The arterial line was placed by healthcare provider at 2am, and the patient alarming for disconnect at 2:30am; the nurse walked into the room to arterial blood spraying proximal connector piece from arterial line was found to have crack in arterial line line had to be replaced at hub.The event occurred during patient use, but harm was not reported as a consequence of this event.

Event Description

Additional information was received via medsun mandatory medwatch report (mdr report #: (b)(4)) that stated: ¿arterial line disconnected related to faulty equipment.The arterial line was placed by the provider at 2am, the patient was alarmed for disconnect at 2:30am, the nurse walked in room to arterial blood spraying proximal connector piece from arterial line found to have a crack in it.Arterial line had to be replaced at hub.¿ the location where the event occurred was at the hospital critical care.

Manufacturer Narrative

The complaint could not be confirmed.No product samples, pictures, or videos were received for investigation.Therefore, a comprehensive failure investigation cannot be performed and a cause cannot be determined.A manufacturing record review could not be completed as the lot number was not provided by the customer.The lot history review could not be conducted because no lot number(s) was/were identified.

• Brand Name: MONITORING KIT W/SAFESET¿ II, 03 ML FLUSH DEVICE & MARVELOUS VALVE
• Type of Device: 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: 18546419
• MDR Text Key: 333518130
• Report Number: 9617594-2024-00050
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 460990471
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1