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

Model Number 1203012

Device Problem Particulates (1451)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned.It has not yet been received.

Event 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.

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.

Manufacturer Narrative

Corrected information in date received by manufacturer.

• Brand Name: PLUMSET-W/2 CLAVE 1'S
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• MDR Report Key: 8267315
• MDR Text Key: 133742715
• Report Number: 9615050-2019-00010
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10887787005193
• UDI-Public: (01)10887787005193(17)200901(10)810465H
• Combination Product (y/n): N
• PMA/PMN Number: K141789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 12/28/2018
• Initial Date FDA Received: 01/22/2019
• Supplement Dates Manufacturer Received: 04/04/2018; 04/04/2019
• Supplement Dates FDA Received: 04/24/2019; 04/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1