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¿, 2 TRI-CONNECTORS, BACK CHECK V; STOPCOCK, I.V. SET

Catalog Number	B33973
Medical Device Problem Codes	Break (1069); Disconnection (1171); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for evaluation, however, a lot history review will be performed in due course.
Event or Problem Description
It was reported that the 14" (36 cm) appx 3.6 ml, transfer set w/4 clave¿, 2 tri-connectors, back check valve, clamp (blue), vented cap had a disconnection issue.It was stated that the item broke/disconnected where it should have been fused.Unspecified medication splashed onto a nurse and the onto the floor.This is the same area where other manifolds have failed in the past.The medication involved was mycophenolate.There was patient involvement and rn was sprayed with hazardous drug.The hazardous drug has no effect to the rn and the patient.There were no patient harm.
Additional Manufacturer Narrative
The complaint could not be confirmed by investigation.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 lot history was reviewed, and no nonconformities were found that would have led to the reported complaint.
Event or Problem Description
Additional information received.A medsun medwatch uf/importer report # (b)(4) received on 27-jan-2025 that stated physical therapy (pt), occupational therapy (ot), and registered nurse (rn) were mobilizing patient when a portion of the 4-port manifold that had been infusing hazardous drugs fell apart.Medication started to fall freely onto the floor and mycophenolate splashed onto primary nurse's arm.A second nurse was able to plug the hole without getting splashed.The primary nurse washed her arm immediately and both nurses notified the charge nurse of a hazardous drug spill.Additional event information obtained from ufmw: this is a single-use device that was not reprocessed and reused on a patient.This is a device that was not ever services by a third-party servicer.One day is the approximate age of device.The event occurred in the hospital critical care.
Additional Manufacturer Narrative
Additional information in a2, a3, a4, b5, e4, g2, and h10.

• Brand Name: 14" (36 CM) APPX 3.6 ML, TRANSFER SET W/4 CLAVE¿, 2 TRI-CONNECTORS, BACK CHECK V
• 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: 21035656
• Report Number: 9617594-2024-01885
• Device Sequence Number: 7656438
• Product Code: FMG
• UDI-Device Identifier: 00887709123984
• UDI-Public: (01)00887709123984(17)290701(10)14089521
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• 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: 14089521
• 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: 12/02/2024
• Supplement Date Received by Manufacturer: 01/08/2025; 01/27/2025
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 01/15/2025; 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2024
• 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 Age: 66 YR
• Patient Sex: Male
• Patient Weight: 72 KG