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
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Chemical Exposure (2570)
Date of Event	05/11/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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®
• Common Device Name: 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: 8139860
• Report Number: 9617594-2018-00218
• Device Sequence Number: 11310274
• Product Code: FMG
• UDI-Device Identifier: 00840619084592
• UDI-Public: (01)00840619084592(17)220901(10)3524123
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K082836
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/12/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/01/2022
• Device Catalogue Number: 886-CH-14
• Device Lot Number: 3524123
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2018
• Initial Report FDA Received Date: 12/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1