MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX 0.39 ML, PRESSURE INFUSION (400PSIG) EXT SET W/MICROCLAVE® CLEAR; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MC33450
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for evaluation.It is yet to be received.Concomitant products: covidien monoject tube holder (item number 8881225216), carefusion maxguard extension set with two needleless y-sites (item number mx9178), covidien vacutainer (unknown item number).
Event or Problem Description
The event involves a customer report of pressure infusion (400psig) ext set w/microclave® clear that had blood flowing out of it.It was reported an intravenous (iv) line was started on a patient, blood was drawn from the iv hub using a covidien vacutainer, then the extension set was connected to the iv hub and fluids started.The device was replaced.There was patient involvement, but no adverse event or delay in critical therapy.
Additional Manufacturer Narrative
Date returned to mfg: 4/17/2019.A sample was returned with a green cap on the female luer of the microclave and when the cap was removed had a seal stick down.The green cap did not have any features that would have been able to depress the seal into a stuck down position so the green cap is not the likely cause of the seal stick down.Subsequent disassembly revealed a seal tearing to the outer edge of the seal typical of access with an incompatible mating device.Two mating devices were returned for evaluation and measured.The probable cause of the microclave seal stick down and subsequent leakage in using incompatible mating device.The microclave dfu states: connectors are compatible with iso male luers having an internal diameter between 0.062" and 0.110".A lot review was performed and no issues were found.

• Brand Name: 7" (18 CM) APPX 0.39 ML, PRESSURE INFUSION (400PSIG) EXT SET W/MICROCLAVE® CLEAR
• 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
• MDR Report Key: 8522982
• Report Number: 9617594-2019-00119
• Device Sequence Number: 2689480
• Product Code: FPA
• UDI-Device Identifier: 00887709038905
• UDI-Public: (01)00887709038905(17)231201(10)3920630
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K100576
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2019

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: 12/01/2023
• Device Catalogue Number: MC33450
• Device Lot Number: 3920630
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/25/2019
• Supplement Date Received by Manufacturer: 04/29/2019
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 05/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1