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 Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was discarded.The dhr was reviewed and there were no non-conformances found that would have contributed to the reported complaint.A probable cause cannot be identified based on the information that has been provided.
Event or Problem Description
The customer reported that a vented bag spike was found broken and was leaking chemotherapy drug at the assembly (between blue spike and white female luer).The device was replaced with no further issues.There was patient involvement, but no adverse event or medical intervention.

• 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: 8256625
• Report Number: 9617594-2019-00014
• Device Sequence Number: 2285713
• Product Code: FMG
• UDI-Device Identifier: 00840619084592
• UDI-Public: (01)00840619084592(17)230201(10)3630509
• 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): 12/20/2018

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: 02/01/2023
• Device Catalogue Number: 886-CH-14
• Device Lot Number: 3630509
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2018
• Initial Report FDA Received Date: 01/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BEVACIZUMAB