MAUDE Adverse Event Report: ICU MEDICAL MICROCLAVE; ADMIN SET

Model Number	MC33098
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	05/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not returned.No additional information was provided by the initial reporter.A two year review of complaints database revealed no additional reports for mc33098/similar problem.
Event or Problem Description
Rotating luers very easily popped off any ambulatory patients.Caused chemo spill, blood spills, tpn spills and other medication and drug spills.Unprotected chemo exposure was reported.
Additional Manufacturer Narrative
Device not returned.No additional information was provided by the initial reporter.A two year review of complaints database revealed no additional reports for mc33098/similar problem.
Event or Problem Description
Rotating luers very easily popped off any ambulatory patients.Caused chemo spill, blood spills, tpn spills and other medication and drug spills.Unprotected chemo exposure was reported.The actual devices were not returned.The exact cause of the events and disconnects remain unknown.Although there was an unscheduled device change out there was no critical delay in therapy, no change in patient's baseline clinical condition and no emergent medical treatments or interventions.

• Brand Name: MICROCLAVE
• Common Device Name: ADMIN SET
• Manufacturer (Section D): ICU MEDICAL; 4455 atherton drive; salt lake city UT 84117
• MDR Report Key: 6796073
• Report Number: 2025816-2017-00193
• Device Sequence Number: 16173341
• Product Code: FMG
• UDI-Device Identifier: 00887709037366
• UDI-Public: 887709037366
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K964435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2017

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: Health Professional
• Device Model Number: MC33098
• Device Catalogue Number: MC33098
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/19/2017
• Supplement Date Received by Manufacturer: 07/19/2017
• Initial Report FDA Received Date: 08/15/2017
• Supplement Report FDA Received Date: 09/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1