MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 71" EXT SET W/MICROCLAVE® CLEAR, 3 GANG 1O2® MANIFOLD W/BASEPLATE (BLUE, GREEN,; STOPCOCK, I.V. SET

Model Number	MC5008
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.It has not been received.
Event or Problem Description
The event involved a 71" ext set w/microclave® clear, 3 gang 1o2® manifold w/baseplate (blue, green, yellow), check valve, 3 remv ext w/3 remv microclave® clear, 1 remv smallbore ext w/clave® clear, clamp where it was reported that the tubing has debris on it but unsure if any debris are within the tubing.The debris looked cloudy white sticky residue outside of the tubing.The reporter added that the device was considered contaminated and had to open another tubing.The incident happened in the operating room.The particulate was noted first in the original hospira container.The product is stored in room temperature with all other sterile anesthesia supplies based on ornac standards.There was no report of patient involvement or patient harm.
Additional Manufacturer Narrative
Received one used extension set (mc5008) with dry fluid residuals on the outside of the tubing that was attached to the yellow port on the manifold.The dry residual was also on the outside of the female luer bonded to the tubing and on the outside of the clear microclave.Subsequent leak testing did not reveal any leakage at any bond or connection location.This suggests that the fluid residue came from an external source.The probable cause of the fluid residuals on the outside of the tubing, female luer, and microclave cannot be determined but was unlikely to have originated from the mc5008 extension set fluid path due to damage or a manufacturing defect.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 71" EXT SET W/MICROCLAVE® CLEAR, 3 GANG 1O2® MANIFOLD W/BASEPLATE (BLUE, GREEN,
• 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: 13048182
• Report Number: 9617594-2021-00312
• Device Sequence Number: 1662433
• Product Code: FMG
• UDI-Device Identifier: 00887709068421
• UDI-Public: (01)00887709068421(17)260501(10)5376571
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2021

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: 05/01/2026
• Device Model Number: MC5008
• Device Catalogue Number: MC5008
• Device Lot Number: 5376571
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2021
• Supplement Date Received by Manufacturer: 12/30/2021
• Initial Report FDA Received Date: 12/20/2021
• Supplement Report FDA Received Date: 01/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2021
• 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