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	03/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is not available for investigation.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 involves a plum set that was reported orange liquid flowed out when infusing normal saline.The customer stated they suspect dye in tubing is running out.No additional information 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: 10118931
• Report Number: 9615050-2020-00083
• Device Sequence Number: 13893808
• Product Code: FRN
• UDI-Device Identifier: 10887787009023
• UDI-Public: (01)10887787009023(17)210901(10)937325H
• 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: foreign,health professional
• 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: 09/01/2021
• Device Model Number: 1187912
• Device Catalogue Number: 118790412
• Device Lot Number: 937325H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2020
• Initial Report FDA Received Date: 06/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1