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
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following was returned by the customer for complaint investigation: one used list #460990471, monitoring kit w/safeset¿ ii, 03 ml flush device & marvelous valve; lot #14071485.The reported complaint of syringe disconnected was confirmed.Images were provided by the customer showing the syringe cap dislodged from the safeset reservoir.During visual inspection of the sample, the syringe cap was received disconnected from the reservoir.No plastic deformations were observed on the syringe cap.Per the configuration of the set, the syringe cap is a snap fit to the safeset reservoir.The probable cause of the syringe cap being disconnected had occurred due to an error during assembly in manufacturing.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.
Event or Problem Description
The complaint/event involved a monitoring kit w/safeset¿ ii, 03 ml flush device and marvelous valve.The report states that the arterial line syringe did not clip into place.It appeared that the white disc above the syringe is loose preventing the clips to secure into rest of device.There was no adverse event.
Event or Problem Description
Additional information was received via medsun medwatch uf/importer report #(b)(4) on 04-dec-2024 that stated ¿arterial line syringe does not clip into place.Looks like the white disc above the syringe is loose preventing the clips to secure into rest of device.¿ additional event information obtained from ufmw: the report was completed by anna cerilli a nurse of yale-new haven hospital.The date of this report was nov-2024.This is a product problem with the event date on oct-2024.The suspect medical device is a monitoring kit w/safeset¿ ii, 03 ml flush device & marvelous valve with item number 46099-71 and lot number 14071485, common device name transducer, blood-pressure, extravascular.This is not single-use device that was reprocessed and reused on a patient.The device was not available for evaluation since it was already returned to manufacturer.This device was not serviced by a third-party service.This is not a laboratory device or laboratory test.This is an initial type of report.The location where event occurred was in the hospital¿s critical care.The report was sent to the manufacturer.The type of reportable event is malfunction".
Additional Manufacturer Narrative
The medsun medwatch uf/importer report # should have been included in previous report; this number has not been added to section h10.

• Brand Name: MONITORING KIT W/SAFESET¿ II, 03 ML FLUSH DEVICE & MARVELOUS 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: 20800700
• Report Number: 9617594-2024-01703
• Device Sequence Number: 7809808
• Product Code: DRS
• UDI-Device Identifier: 00840619069087
• UDI-Public: (01)00840619069087(17)270701(10)14071485
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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,Followup
• Report Date (Section B): 01/28/2025

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: 460990471
• Device Lot Number: 14071485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2024
• Supplement Date Received by Manufacturer: 12/04/2024; 01/28/2025
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 01/01/2025; 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2024
• 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