MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. RANSPAC® IV MONITORING KIT W/03 ML SQUEEZE FLUSH DEVICE, SAMPLING PORT, 10 CC; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number	46115-10
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.
Event or Problem Description
The complaint/event occurred on an unspecified date and involved a transpac® iv monitoring kit w/03 ml squeeze flush device, sampling port, 10 cc contamination sheath syringe and admin set.The customer reported that the arterial pressure tubing snapped apart in the middle of the tubing (not near the connection sites) immediately upon use at the hospital.There was patient involvement and no adverse event or human harm.This is the first of four reports.
Additional Manufacturer Narrative
The complaint could not be confirmed.No product samples, pictures, or videos were received for investigation.Without the return of the used sample, a comprehensive failure investigation cannot be performed and a cause cannot be determined.The device history record was reviewed and no nonconformities were found that would led to the reported complaint.Corrected information can be found in h6 medical device problem code.Updated information can be found in d9.

• Brand Name: RANSPAC® IV MONITORING KIT W/03 ML SQUEEZE FLUSH DEVICE, SAMPLING PORT, 10 CC
• 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: 18633445
• Report Number: 9617594-2024-00082
• Device Sequence Number: 7889097
• Product Code: DRS
• UDI-Device Identifier: 00887709082496
• UDI-Public: (01)00887709082496(17)260601(10)13655886
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 07/23/2024

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 Expiration Date: 06/01/2026
• Device Catalogue Number: 46115-10
• Device Lot Number: 13655886
• 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: 01/04/2024
• Supplement Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 02/02/2024
• Supplement Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2023
• 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