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; ADMINISTRATION SETS AND ACCESSORIES

Catalog Number	MC33450
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Blood Loss (2597)
Date of Event	03/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device involved in the event is expected to be returned to the manufacturer for further investigation however it has not yet been received.
Event or Problem Description
It was reported that once the intravenous treatment was started on the patient, blood was drawn from the hub, then started flowing out of the device nonstop.The device involved in the event was reported to be replaced without further incident.There was patient involvement however there was no adverse event, harm, or delay in critical therapy reported.No additional information is known at this time.
Additional Manufacturer Narrative
Concomitant medical products: 4/17/2019.The device was received, 4/17/2019 for further evaluation.The returned extension set was pressure leak tested and was found to leak from the damaged microclave.Further testing revealed a seal puncture and spike damage typical of access with an incompatible mating device(s).The probable cause of the microclave seal stick down and reported leakage is access with an incompatible mating device during use.

• Brand Name: 7" (18 CM) APPX 0.39 ML, PRESSURE INFUSION (400PSIG) EXT SET W/MICROCLAVE® CLEAR
• Common Device Name: ADMINISTRATION SETS AND ACCESSORIES
• 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: 8524543
• Report Number: 9617594-2019-00120
• Device Sequence Number: 1885021
• Product Code: FPA
• UDI-Device Identifier: 00887709038905
• UDI-Public: (01)00887709038905(17)231101(10)3870859
• 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,distri
• Initial Reporter Occupation: Other Health Care 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: 11/01/2023
• Device Catalogue Number: MC33450
• Device Lot Number: 3870859
• 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: 05/23/2019
• 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: CAREFUSION MAXGUARD EXTENSION SET.; COVIDEIN VACUTAINER.; COVIDIEN MONOJECT TUBE HOLDER.