MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 38 CM (15") SMALLBORE EXT SET W/3 MICROCLAVE® CLEAR, RINGS (GLOW, RED), ROTATING; STOPCOCK, I.V. SET

Catalog Number 011-MC330211

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/02/2019

Event Type  malfunction  

Manufacturer Narrative

The device is available for evaluation.It is yet to be received.

Event Description

The event involved a smallbore extension set w/microclave clear that leaked noradrenaline at the white channel, at the level of the check valve.The customer reported the valves are damaged.The device was replaced.There is patient involvement with a delay in therapy, but no reported harm.

Manufacturer Narrative

H10: one (1) used list# 011-mc330211, 38 cm (15") smallbore ext set w/3 microclave® clear, rings (glow, red), rotating luer was received on (b)(6) 2020 for investigation.The returned sample was received with a stick down on the proximal y-clave and the distal microclave.This type of stick down can lead to the reported complaint of leakage.The y-clave and microclave were each disassembled and the internal spike were broken or crushed.Each of the silicone seals were also observed to have slit prorogation.The probable cause of the damage to the spike and seal of the y-clave and microclave is due to accessing the needless device with an incompatible mating device.Per the directions for use: connectors are compatible with iso male luers having an internal diameter between 0.062¿ and 0.110¿.Access connectors straight on.(without angled or sliding entry).No device history review was conducted since no lot number was identified.Additional information in d1, d4, and h3.

• Brand Name: 38 CM (15") SMALLBORE EXT SET W/3 MICROCLAVE® CLEAR, RINGS (GLOW, RED), 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: 9507113
• MDR Text Key: 187698890
• Report Number: 9617594-2019-00430
• 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: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-MC330211
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NORADRENALINE, MFR UNK