MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. VENTED BAG SPIKE, CLAVE®; STOPCOCK, I.V. SET

Catalog Number 886-CH-14

Device Problem Fluid/Blood Leak (1250)

Patient Problems No Consequences Or Impact To Patient (2199); Chemical Exposure (2570)

Event Date 05/11/2018

Event Type  malfunction  

Manufacturer Narrative

The device was discarded however the manufacturer received photos for review.The probable cause for the leak was found to be vent damage caused during the infusion.A device history review (dhr) did not reveal non-conformances that would have contributed to the reported event.No additional information was obtained.

Event Description

It was reported that a vented bag spike leaked an unspecified chemotherapeutic agent through the air vent during an infusion.The device was reported to have been replaced and therapy was resumed without incident.There was no report of patient harm as a result of the event.No additional information was received.

• Brand Name: VENTED BAG SPIKE, CLAVE®
• 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
• Manufacturer Contact: patricia sharpe-gregg, bsn, rn ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 8139860
• MDR Text Key: 129578801
• Report Number: 9617594-2018-00218
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619084592
• UDI-Public: (01)00840619084592(17)220901(10)3524123
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 11/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2022
• Device Catalogue Number: 886-CH-14
• Device Lot Number: 3524123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2017
• 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