MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PLUMSET-W/2 CLAVE 1'S; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	1203012
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned.It has not yet been received.
Event or Problem Description
The event involved a plum set on an unspecified date that was reported to have impurities inside the tube.There was no report of human harm, nor adverse event, nor medical intervention.
Additional Manufacturer Narrative
One (1) used list number 120300412 lifeshield primary plumset clave port clave y-site was received for evaluation.As received, particulate is observed within the tubing of the returned used plum set.The particulate was isolated from the tubing and submitted for ft-ir analysis.The ft-ir revealed that the particulate closely matched a dextrose solution.The infusate administered was not provided by the customer.The probable cause of the observed particulate is infusate residual accumulated during use.A batch record review was performed to lot# 810465h, list# 120300412 and no discrepancies that may have contributed to a complaint of this nature were found.
Additional Manufacturer Narrative
Corrected information in date received by manufacturer.

• Brand Name: PLUMSET-W/2 CLAVE 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: 8267315
• Report Number: 9615050-2019-00010
• Device Sequence Number: 2082364
• Product Code: FPA
• UDI-Device Identifier: 10887787005193
• UDI-Public: (01)10887787005193(17)200901(10)810465H
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K141789
• 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,Followup,Followup
• Report Date (Section B): 12/28/2018

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: 09/01/2020
• Device Model Number: 1203012
• Device Catalogue Number: 120300412
• Device Lot Number: 810465H
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/28/2018
• Supplement Date Received by Manufacturer: 04/04/2018; 04/04/2019
• Initial Report FDA Received Date: 01/22/2019
• Supplement Report FDA Received Date: 04/24/2019; 04/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1