MAUDE Adverse Event Report: ICU MEDICAL INC. CLAVE IV BAG ACCESS

Model Number 011-CS-10

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/09/2017

Event Type  malfunction  

Manufacturer Narrative

A review of the mfg.Lot build database for the reported lot number 3187450 (mfg.01/2016 exp.01/2021) recorded (b)(4) units were mfg., tested, inspected and released.The lot review showed all visual, dimensional and functional qc unit testing met all specifications.There were no exception or rejection documents generated during the lot build.The involved device/set-up have not been returned for analysis and confirmation.The exact cause(s) of the reported event/issue at this time remain unknown.

Event Description

Int'l.((b)(6)) complaint received reporting leakage incident with use of 011-cs-10 clave iv bag access device.The report (as translated) describes the event as follows ".Connected the (chemo) infusion set to the spike, the patient informed the operator about a liquid leakage from spike.The device was already inserted into the bag.".There were no reported adverse patient consequences and/or reports of unprotected chemo exposures.The mfr.Has requested additional event information as well as the device return status.As of the date of this report there has been no response.

• Brand Name: CLAVE IV BAG ACCESS
• Type of Device: CLAVE IV BAG ACCESS
• Manufacturer (Section D): ICU MEDICAL INC.; 4455 atherton dr.; salt lake city UT 84123
• Manufacturer (Section G): ICU MEDICAL INC.; 4455 atherton dr.; salt lake city UT 84123
• Manufacturer Contact: terry scesny ; 4455 atherton dr.; salt lake city, UT 84123 ; 8012641400
• MDR Report Key: 6557237
• MDR Text Key: 74993490
• Report Number: 2025816-2017-00096
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K082836
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/27/2016
• Device Model Number: 011-CS-10
• Device Catalogue Number: 011-CS-10
• Device Lot Number: 3187450
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1