MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 17" EXT SET W/0.2 MICRON FILTER, MICROCLAVE CLEAR, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Model Number	MC9079
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample is available for evaluation.It is yet to be received.
Event or Problem Description
The customer reported a 17" ext set w/0.2 micron filter, microclave® clear, clamp, rotating luer that had air in the iv tubing when changing out the lines.No additional information was provided.
Additional Manufacturer Narrative
Three (3) new list# mc9079, extension sets (lot# 4915987) were received on november 9, 2020 and visually inspected.As received, no damage or anomalies were seen on any of the returned sets.No used product or mating devices were returned.Each extension set was primed with water at gravity pressure and then leak tested according to product performance specifications.No leaks or air bubbles were seen.The reported complaint could not be replicated or confirmed.A device history review for lot# 4915987 and relevant commodities were reviewed, and no non-conformances were found that would have contributed to the reported complaint.

• Brand Name: 17" EXT SET W/0.2 MICRON FILTER, MICROCLAVE CLEAR, CLAMP, ROTATING LUER
• 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
• MDR Report Key: 10790770
• Report Number: 9617594-2020-00473
• Device Sequence Number: 19756484
• Product Code: FMG
• UDI-Device Identifier: 00887709078161
• UDI-Public: (01)00887709078161(17)250601(10)4915987
• 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: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2020

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: 06/01/2025
• Device Model Number: MC9079
• Device Catalogue Number: MC9079
• Device Lot Number: 4915987
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/16/2020
• Supplement Date Received by Manufacturer: 11/18/2020
• Initial Report FDA Received Date: 11/05/2020
• Supplement Report FDA Received Date: 11/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1