MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14" (36 CM) APPX 3.6 ML, TRANSFER SET W/4 CLAVE¿; STOPCOCK, I.V. SET

Catalog Number	B33973
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation.Without the return of the sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.A lot number has not been provided, a device history lot review cannot be performed.
Event or Problem Description
The event occurred on an unspecified date in december 2024 and involved a 14" (36 cm) appx 3.6 ml, transfer set w/4 clave¿, 2 tri-connectors, back check valve, clamp (blue), vented cap.A medsun medwatch uf/importer report # (b)(4) was received on 27-jan-2025 that stated the patient was receiving iv gancyclovir.A 5% dextrose iv flush bag was attached to a 4 port manifold and the iv gancyclovir was piggybacked.One of the claves from the manifold came off and the iv medication leaked out of the lumen of the manifold.The medication did not reach the patient, however the staff and transport rn came in contact with the hazardous medication.This is not a single-use device that was reprocessed and reused on a patient.Approximate age of device is 1 day.There was patient involvement and unknown adverse event.

• Brand Name: 14" (36 CM) APPX 3.6 ML, TRANSFER SET W/4 CLAVE¿
• Common Device Name: STOPCOCK, I.V. SET
• 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: 21448207
• Report Number: 9617594-2025-00341
• Device Sequence Number: 15393939
• Product Code: FMG
• UDI-Device Identifier: 00887709123984
• UDI-Public: 00887709123984
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K964435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 02/24/2025

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: B33973
• Device Lot Number: UNKNOWN
• 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: 01/27/2025
• Initial Report FDA Received Date: 02/24/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 5% DEXTROSE IV FLUSH BAG, BAXTER.; IV GANCYCLOVIR, UNK MFR.
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 62 KG