MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. CLAVE PLUMSET SOL 150X60 1'S; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 1194802

Device Problem Particulates (1451)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2019

Event Type  malfunction  

Manufacturer Narrative

The device involved in the event is expected to be returned to the manufacturer for further evaluation but has not yet been received.In the event that additional information is received, a supplemental report will be submitted.

Event Description

It was reported that, on an unspecified date, the tubing involved in the event was noticed to have unknown impurities in the fluid path of the patient.There was unknown patient involvement reported.No additional information is known at this time.

Manufacturer Narrative

Device available for evaluation: 5/30/2019.The returned device was received with residual medication in the set.The burette was examined, as received, and a small particle was observed in the residual solution.The reported complaint can be confirmed; however, as the set was returned with the residual solution, the probable cause of the particle is unknown.The device history review did not reveal any non-conformances that may have contributed to a report of this nature.

• Brand Name: CLAVE PLUMSET SOL 150X60 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: 8609640
• MDR Text Key: 145114470
• Report Number: 9615050-2019-00154
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10887787005179
• UDI-Public: (01)10887787005179(17)210401(10)886705H
• 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
• Report Date: 04/24/2019

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: 04/01/2021
• Device Model Number: 1194802
• Device Catalogue Number: 119480402
• Device Lot Number: 886705H
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/24/2019
• Initial Date FDA Received: 05/14/2019
• Supplement Dates Manufacturer Received: 06/13/2019
• Supplement Dates FDA Received: 07/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1