MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. EXT. CON 2 CLAVE®, 22 CM, APX. 1,1 ML, CLAMPA Y LUER ROTAT.; STOPCOCK, I.V. SET

Catalog Number 034-C4203-2

Device Problem Fluid/Blood Leak (1250)

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

Event Date 04/16/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The event involved an extension set that while disconnecting the gravity set from the clave connector of the extension set, the silicone was not closed well and a small amount of blood loss was noted.There was patient involvement, but no harm reported.

Manufacturer Narrative

It was previously reported the device was available for evaluation; however, no (b)(4) product samples were returned for investigation.Several photographs were returned showing an integrated y-clave with what appears to be a cored hole in the silicone seal.No device history review was conducted because no lot number(s) was/were identified.The complaint can be confirmed from the photographs.The probable cause is access with an incompatible mating device during use.The directions for use states: y-clave connectors are compatible with iso male luers having an internal diameter between 0.062" and 0.110".

• Brand Name: EXT. CON 2 CLAVE®, 22 CM, APX. 1,1 ML, CLAMPA Y LUER ROTAT.
• 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: 8657586
• MDR Text Key: 147343404
• Report Number: 9617594-2019-00153
• 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: 05/02/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 034-C4203-2
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/06/2019
• Initial Date FDA Received: 05/31/2019
• Supplement Dates Manufacturer Received: 06/14/2019
• Supplement Dates FDA Received: 06/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSP GRAVITY SET