MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC¿ IV QUAD MONITORING KIT W/03 ML SQUEEZE FLUSH DEVICES, STOPCOCKS, NEEDL; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number	46117-18
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.If a return or any additional information is later received, then a supplemental emdr will be submitted at that time.
Event or Problem Description
The event involved a transpac¿ iv quad monitoring kit w/03 ml squeeze flush devices, stopcocks, needleless valve and arterial pressure tubing where it was reported that the quads transducers were broken during use on patients in the cvic (cardiovascular intensive care unit).There was no patient harm associated with the event.
Additional Manufacturer Narrative
The reported complaint of separation was confirmed.No product samples, or videos were received for investigation.However, images were provided by the customer showing a safeset separation and a breakage at the squeeze flush device.Without the return of the reported sample, a probable cause could not be identified.The device history review for lot 13909878 was reviewed and no non conformities were found that would led to the reported complaint.

• Brand Name: TRANSPAC¿ IV QUAD MONITORING KIT W/03 ML SQUEEZE FLUSH DEVICES, STOPCOCKS, NEEDL
• 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: 19589524
• Report Number: 9617594-2024-00802
• Device Sequence Number: 15273708
• Product Code: DRS
• UDI-Device Identifier: 00887709097544
• UDI-Public: (01)00887709097544(17)270201(10)13909878
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K061573
• Number of Events Summarized: 1
• Summary Report (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): 07/31/2024

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: 46117-18
• Device Lot Number: 13909878
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2024
• Supplement Date Received by Manufacturer: 07/03/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 07/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2024
• 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