MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4" (10 CM) APPX 0.40 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE®, 3 CLAMPS, RO; STOPCOCK, I.V. SET

Model Number	B33098
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for evaluation.It is yet to be received.
Event or Problem Description
The customer reported a patient was receiving 24 hour chemotherapy when a microclave on a trifuse extension set remained depressed and started leaking fluid.No adverse event was reported; however, the patient had a central line and had an earlier than normal tubing change due to an increased risk of infection.No additional information was provided.
Additional Manufacturer Narrative
No b33098 or ch2000s-c product samples, videos, or photographs were returned for investigation.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.

• Brand Name: 4" (10 CM) APPX 0.40 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE®, 3 CLAMPS, RO
• 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: 8537264
• Report Number: 9617594-2019-00125
• Device Sequence Number: 16751822
• Product Code: FMG
• UDI-Device Identifier: 00887709006263
• UDI-Public: (01)00887709006263(17)240201(10)3989844
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K964435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2019

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: 02/01/2024
• Device Model Number: B33098
• Device Catalogue Number: B33098
• Device Lot Number: 3989844
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/03/2019
• Supplement Date Received by Manufacturer: 05/16/2019
• Initial Report FDA Received Date: 04/22/2019
• Supplement Report FDA Received Date: 05/21/2019
• 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: SPIROS (LIST # CH2000S-C).