MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX 0.45 ML, PRESSURE INFUSION (400PSIG) EXT SET W/ MICROCLAVE® CLEA; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	12514-01
Medical Device Problem Codes	Backflow (1064); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A single used 7" (18 cm) appx 0.45 ml, pressure infusion (400psig) ext set w/ microclave¿ clear, purple clamp, rotating luer was returned for evaluation.Testing found the shuntless microclave was separated at the tube bond.The tube bond was visually examined and there was no evidence of solvent on the tubing or at the bond pocket of the shuntless microclave.The bond pocket and tubing were measured and found to be within specification.The probable cause of the bond separation is no solvent application during manual assembly in ensenada.A device history review was reviewed and there were no relevant non-conformances found.
Event or Problem Description
The event involved a 7" appx 0.45 ml, pressure infusion (400psig) ext set w/ microclave® clear, purple clamp, rotating luer, where the clave came off just after the iv start and blood backed up through the tubing and leaked from the end.The nurse immediately clamped the tubing and replaced it.There was no adverse event.

• Brand Name: 7" (18 CM) APPX 0.45 ML, PRESSURE INFUSION (400PSIG) EXT SET W/ MICROCLAVE® CLEA
• 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: 8546465
• Report Number: 9617594-2019-00126
• Device Sequence Number: 2457998
• Product Code: FPA
• UDI-Device Identifier: 00887709044470
• UDI-Public: (01)00887709044470(17)231001(10)94-182-SJ
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/02/2019

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: 10/01/2023
• Device Catalogue Number: 12514-01
• Device Lot Number: 94-182-SJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2019
• Initial Report FDA Received Date: 04/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1