MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SAFESET 24" ARTERIAL PRESSURE TUBING, SAFESET RESERVOIR AND BLOOD SAMPLING PORT; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number	423280402
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4, g4: model number is not sold in the us but similar device is sold under model 42801-29.This product was used for the di, product code, and 501k.D4 and h4 the lot#, expiration date, and manufacture date are unknown.The investigation is pending completion.Upon completion a supplemental mdr will be submitted.
Event or Problem Description
A complaint was received regarding a safeset¿ 24 inch arterial pressure tubing, safeset¿ reservoir and blood sampling port that experienced leakage.The report states that "while drawing bloodwork from the patient's arterial line, the safeset appears to have cracked and began leaking blood (at tip of safeset plunger)".The customer does not require immediate replacement to be able to continue operations.Quantity affected and quantity to be returned is 1 ea.Date of incident was on (b)(6) 2025.There was patient involvement, no adverse event and there was delay in therapy.
Additional Manufacturer Narrative
Investigation summary the reported 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.

• Brand Name: SAFESET 24" ARTERIAL PRESSURE TUBING, SAFESET RESERVOIR AND BLOOD SAMPLING PORT
• 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: 21922922
• Report Number: 9617594-2025-00857
• Device Sequence Number: 15631532
• Product Code: DRS
• UDI-Device Identifier: 00887709120785
• UDI-Public: 00887709120785
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K052828
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2025

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: 423280402
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2025
• Supplement Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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