MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC® IV MONITORING KIT W/SAFESET 84" ARTERIAL PRESSURE TUBING, RESERVOIR,03; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number	42646-66
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received a medsun mandatory medwatch report (uf/importer report# (b)(4)).The incident involved a transpac® iv monitoring kit w/safeset 84" arterial pressure tubing, reservoir,03 ml squeeze flush and 2 needleless valves.The report stated that the statlock tubing from the arterial line severed during attachment to a brand new transducer set-up.It seems it was the statlock tubing that severed (not the transducer tubing).Meaning the transducer is intact but the end of the transducer that is affixed to the statlock tubing severed.There was unknown patient involvement and no patient harm reported.
Additional Manufacturer Narrative
It is unknown if the device will be returned for evaluation.Without the return of the sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.If the device is returned, a supplemental report will be filed.
Additional Manufacturer Narrative
No sample was returned for evaluation.An image was provided by the customer showing the tubing separation/breakage.The reported complaint of separation/breakage was confirmed as a result of the photograph review.Without the return of the reported sample, a probable cause could not be determined.The lot history was reviewed and no commodities were identified which could lead to the reported complaint.

• Brand Name: TRANSPAC® IV MONITORING KIT W/SAFESET 84" ARTERIAL PRESSURE TUBING, RESERVOIR,03
• 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: 18183494
• Report Number: 9617594-2023-01015
• Device Sequence Number: 7889831
• Product Code: DRS
• UDI-Device Identifier: 00887709042605
• UDI-Public: (01)00887709042605(17)260101(10)13515407
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2024

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: 01/01/2026
• Device Catalogue Number: 42646-66
• Device Lot Number: 13515407
• 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: 11/03/2023
• Supplement Date Received by Manufacturer: 01/22/2024
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 01/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2023
• 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