MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. NONVENTED PLUM SET 1'S; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	1187912
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is unavailable for evaluation.Without the return of the sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.
Event or Problem Description
The event reported is a plum set with contaminant in infusion tubing.No additional information has been provided.

• Brand Name: NONVENTED PLUM SET 1'S
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• MDR Report Key: 10134055
• Report Number: 9615050-2020-00140
• Device Sequence Number: 3220727
• Product Code: FRN
• UDI-Device Identifier: 10887787009023
• UDI-Public: (01)10887787009023(17)220101(10)3935434
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K982159
• 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): 02/12/2020

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: 01/01/2022
• Device Model Number: 1187912
• Device Catalogue Number: 118790412
• Device Lot Number: 3935434
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 06/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1