MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE®

Model Number	B33098
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A used b33098 trifuse extension set was returned with one of the lines separated at the bond between the tubing and the trifurcated adapter.Microscopic examination of the bond site revealed that there was no solvent applied at the bond between the tubing and the trifurcated bond pocket.The probable cause of the bond separation is no solvent applied during manual product assembly to the tube bond interface at the trifurcated adapter.No dhr lot review was conducted because no lot number(s) was/were identified.
Event or Problem Description
The event involved a customer report stating that one lumen of a smallbore trifuse extension set w/3 microclave became detached at the hub allowing for free flowing backflow from the central line.There was no serious injury reported.

• Brand Name: SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE®
• Common Device Name: SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; colonia rancho santa clara, ma; ensenada, 22790 ; MX 22790
• MDR Report Key: 7934478
• Report Number: 9617594-2018-00056
• Device Sequence Number: 930421
• Product Code: FMG
• UDI-Device Identifier: 00887709006263
• UDI-Public: 00887709006263
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/18/2018

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 Model Number: B33098
• Device Catalogue Number: B33098
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2018
• Initial Report FDA Received Date: 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1