MAUDE Adverse Event Report: ICU MEDICAL SMALLBORE EXT. SET

Model Number	MC33904
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot review: a two year review of the complaint database for this list/similar problem did record additional reports and investigations.A review of those investigations where devices were returned recorded mixed results, including no defect found; usage; cannot determine and mfg./ design.Visual inspection: received one (1) used mc33904,72" (183 cm) smallbore ext set w/microclave® clear, 0.2 micron filter, clamp, luer lock, non-dehp tubing; lot # unknown.Functional testing: the one (1) used mc33904 device was primed with water at gravity pressure (1.5 psig).The device was then leak tested and water leaked immediately at gravity pressure (1.5psig) from the crack in the filter housing.Final analysis summary: the reported product problem for leakage at the 0.2 micron filter on the set was confirmed.The leakage was due to a crack in the housing of the filter.There were also stress marks (blushing) near the cracking which appear to be due to some kind of bending force.Icu medical will monitor and trend.
Event or Problem Description
Complaint received regarding one mc33904.Report states: rn reports," at 0900 on (b)(6) 2017 while adding extension tubing to my medication lines for mri, found that the filter on normal medication tubing, was leaking.The patient had high nas scores but baseline improved after the unscheduled changeout and medication resumed.There were no adverse patient consequences reported.

• Brand Name: SMALLBORE EXT. SET
• Common Device Name: SMALLBORE EXT. SET
• Manufacturer (Section D): ICU MEDICAL; 4455 atherton drive; salt lake city UT 84123
• MDR Report Key: 6757763
• Report Number: 2025816-2017-00177
• Device Sequence Number: 1508944
• Product Code: FMG
• UDI-Device Identifier: 00887709071155
• UDI-Public: 887709071155
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K964435
• 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): 08/01/2017

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: MC33904
• Device Catalogue Number: MC33904
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2017
• Initial Report FDA Received Date: 08/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1