MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14" EXT SET W/0.2 MICRON FILTER, CLAVE CLEAR, CLAMP, ROTATING LUER; PRIMARY IV SET

Model Number	MC9013
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/23/2020
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
A user facility mandatory medwatch was received that stated ¿during chemotherapy administration, staff identified small leaks with the icu medical 0.2-micron filters on three separate occasions.Filters pulled off the shelf for review.No staff exposure noted¿.There was patient involvement and no adverse event or patient harm reported.This is the second of three events reported.
Additional Manufacturer Narrative
There were no product samples, videos, or photographs returned for investigation.The dhr for lot number 4799806 was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.A probable cause cannot be identified based on the information that has been provided.

• Brand Name: 14" EXT SET W/0.2 MICRON FILTER, CLAVE CLEAR, CLAMP, ROTATING LUER
• Common Device Name: PRIMARY IV 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
• MDR Report Key: 10537506
• Report Number: 9617594-2020-00403
• Device Sequence Number: 18925512
• Product Code: FMG
• UDI-Device Identifier: 00887709039391
• UDI-Public: (01)00887709039391(17)250401(10)4799806
• 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
• Reporter Type: User Facility
• Report Source: user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2020

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: 04/01/2025
• Device Model Number: MC9013
• Device Catalogue Number: MC9013
• Device Lot Number: 4799806
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/23/2020
• Initial Report FDA Received Date: 09/15/2020
• Supplement Report FDA Received Date: 09/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED CHEMOTHERAPY DRUG, MFR UNK