MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. VERTICAL MOUNT MANIFOLD FOR DUKE UNIVERSITY; STOPCOCK, I.V. SET

Model Number	46056=37
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a vertical mount manifold.It was reported through visualization that blue particulate was in tubing when removed from wrap prior to use.No report of patient harm was noted.
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.
Additional Manufacturer Narrative
The reported complaint of blue particle inside the tubing was confirmed on the returned set.Three (3) images were provided by the customer showing the blue particulate inside the tubing.During visual inspection, a blue particulate was observed inside the tubing.When the manifold handles were popped out of the manifold, flash was observed on one of the holes of the manifold handle.The blue particle observed in the tubing is a part of the manifold handle.The probable cause of the flash on the manifold handle had occurred due to an error during molding at manufacturing plant.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: VERTICAL MOUNT MANIFOLD FOR DUKE UNIVERSITY
• 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 16096146
• Report Number: 9617594-2023-00005
• Device Sequence Number: 15129420
• Product Code: FMG
• UDI-Device Identifier: 00840619068943
• UDI-Public: (01)00840619068943(17)250701(10)6077767
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K964435
• Number of Events Summarized: 1
• Summary Report (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): 12/13/2022

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: 07/01/2025
• Device Model Number: 46056=37
• Device Catalogue Number: 460560437
• Device Lot Number: 6077767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2022
• Supplement Date Received by Manufacturer: 02/02/2023
• Initial Report FDA Received Date: 01/04/2023
• Supplement Report FDA Received Date: 02/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2022
• 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