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

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/08/2018

Event Type  malfunction  

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 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®
• Type of Device: 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
• Manufacturer (Section G): ICU MEDICAL, INC.; 951 calle amanecer; san clemente CA 92673
• Manufacturer Contact: patricia sharpe-gregg, bsn, rn ; 600 n. field drive, 2n; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 7934478
• MDR Text Key: 122816590
• Report Number: 9617594-2018-00056
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709006263
• UDI-Public: 00887709006263
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1