MAUDE Adverse Event Report: ICU MEDICAL INC. 8" (20 CM) APPX 0.49 ML, SMALLBORE EXT SET W/0.2 MICRON FILTER

Model Number	B1434
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot review: a review of suspect lot# 3396088 showed that (b)(4) were manufactured, tested, inspected and released in february 2017 citing no exception documents.Receipt inspection: received two (2) used b1434, 8" (20 cm) appx 0.49 ml, smallbore ext set w/0.2 micron filter, clamp, rotating luer; suspected lot# 3396088.Functional testing: both used b1434 extension sets were primed and pressure leak tested.Both 0.2 micron filters leaked from the filter vents.Microscopic examination showed that there was no manufacturing defect however the leakage was typical of contact with alcohol found in antiseptic wipes and some chemotherapy drugs rich in alcohol content.Qe analysis summary: the 0.2 micron filters assembled into the b1434 extension sets were found to have filter vent leaks.Examination of the filter vents showed damage typical of alcohol contact.Filter performance may be impacted by, use of alcohol; nature of fluid used, concentration and duration of use.Icu medical will monitor and trend.
Event or Problem Description
Complaint received regarding two b1434, report states: during chemotherapy (etoposide) infusion, medication noted to be leaking @ flat section of filter.This happened on two separate days on the same patient.No adverse patient consequences reported.

• Brand Name: 8" (20 CM) APPX 0.49 ML, SMALLBORE EXT SET W/0.2 MICRON FILTER
• Common Device Name: 8" (20 CM) APPX 0.49 ML, SMALLBORE EXT SET W/0.2 MICRON FILTER
• Manufacturer (Section D): ICU MEDICAL INC.; 4455 atherton dr.; salt lake city UT 84123
• MDR Report Key: 6879463
• Report Number: 2025816-2017-00212
• Device Sequence Number: 18974358
• Product Code: FPA
• UDI-Device Identifier: 00887709001657
• UDI-Public: 887709001657
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K941190
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/18/2017

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: Nurse
• Device Model Number: B1434
• Device Catalogue Number: B1434
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2017
• Initial Report FDA Received Date: 09/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1