MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 8" PRESSURE INFUSION (400PSIG) EXT SET W/CLAVE® CLEAR, CLAMP, ROTATING LUER; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	MC33392
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	03/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The event occurred with a 8" pressure infusion (400psig) ext set w/clave® clear, clamp, rotating luer.The customer reported that there was a foreign item within the tubing prior to use.There was no report of patient involvement, no delay in therapy, and no patient harm.
Additional Manufacturer Narrative
One used.List #mc33392, 8" pressure infusion (400psig) ext set w/clave® clear, clamp, rotating luer; lot #5512930.One used.Manufacturer unknown, pink adaptor; lot #unknown.Fluid residuals were observed in the mc33392 pressure infusion ext set as received.A white substance was observed in the y-clave.The size of the foreign substance exceeded visual inspection criteria.The y-clave was disassembled and the foreign matter examined.The white substance was soft and appeared to be a prior infusate.An ft-ir analysis was performed and a close match with castor oil was found.Castor oil is not used in the manufacturing process.The reported complaint can be confirmed.The probable cause is due to prior infusate during use.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 8" PRESSURE INFUSION (400PSIG) EXT SET W/CLAVE® CLEAR, CLAMP, ROTATING LUER
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 14411898
• Report Number: 9617594-2022-00130
• Device Sequence Number: 5592250
• Product Code: FPA
• UDI-Device Identifier: 00887709038370
• UDI-Public: (01)00887709038370(17)260701(10)5512930
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K100576
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/17/2022

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: 07/01/2026
• Device Model Number: MC33392
• Device Catalogue Number: MC33392
• Device Lot Number: 5512930
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2022
• Initial Report FDA Received Date: 05/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2021
• 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