MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CLAVE¿ CONNECTOR IV BAG ACCESS DEVICE; STOPCOCK, I.V. SET

Catalog Number 011-CS-10

Device Problem Particulates (1451)

Patient Problem No Patient Involvement (2645)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.Without the return of the sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.A device history review cannot be completed without a provided lot number.

Event Description

The event occurred on various unspecified dates involving 6 clave¿ connector iv bag access devices with various lots where blue particles were reported to be present at the base of the opening of the fluid path in the fresenius kabi free flex bag after the bag was spiked with the device, either in preparation for compounding or immediately after compounding.The customer reported there was friction as it is inserted deeper into the bag.There was no patient involvement, no adverse event, and no delay in critical therapy.This report reflects 6 of 6 events.

• Brand Name: CLAVE¿ CONNECTOR IV BAG ACCESS DEVICE
• 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; colonia rancho santa clara, ma; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: christopher zanoni ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 8941936
• MDR Text Key: 198331687
• Report Number: 9617594-2019-00292
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-CS-10
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2019
• Date Manufacturer Received: 08/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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