MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14 CM (5.5") SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE CLEAR, 2 CLAMPS, ROTATING; STOPCOCK, I.V. SET

Catalog Number 011-MC33126

Device Problem Fluid/Blood Leak (1250)

Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597)

Event Date 01/20/2021

Event Type  malfunction  

Manufacturer Narrative

The device is available for investigation.It has not been received.

Event Description

The event involved a 14 cm (5.5") smallbore bifuse ext set w/2 microclave® clear, 2 clamps, rotating luer.The customer reported an unspecified quantity of blood was observed flowing at the level of the bifurcation, precisely at the level of the path used to for the blood test.A new device set up was installed, and no other issues were reported.There was patient involvement and no adverse event reported.No additional information has been provided.

Manufacturer Narrative

Device evaluation: one used list #011-mc33126, 14 cm (5.5") smallbore bifuse ext set w/2 microclave® clear, 2 clamps, rotating luer; lot was received and visually inspected.As received, blood residuals were present within the fluid path of one of the lines.No other damage or anomalies were identified.No mating devices were returned.The bifuse set was primed with water at gravity pressure through one microclave and then hydrostatic pressure leak tested per procedure; no leaks were observed.Flow could not be established through the microclave of the second line containing blood residuals.The residuals occluded the tubing.The reported complaint of leaking at the level of the bifurcation could not be replicated or confirmed.A device history review of lot number review could not be conducted because no lot number(s) was/were identified.D9 - device was received on 3/2/21.

• Brand Name: 14 CM (5.5") SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE CLEAR, 2 CLAMPS, ROTATING
• Type of Device: STOPCOCK, I.V. SET
• 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: 11287690
• MDR Text Key: 230563320
• Report Number: 9617594-2021-00034
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-MC33126
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1