MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, 15 MICRON FILTER IN SIGHT CHAMBER, CLAVE SECONDARY PORT, CLAVE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 140013190

Device Problem Particulates (1451)

Patient Problem No Patient Involvement (2645)

Event Date 07/08/2019

Event Type  malfunction  

Manufacturer Narrative

The device is expected to return for investigation; it has not been received.

Event Description

The reporter stated that a foreign black particle was found inside the chamber of the plum set.The event did not happen during patient use and no one was harmed as a result of this event.

Manufacturer Narrative

Received one (1) new list# 140013190 lot# 4033470 prm plum set 15 mcrn fltr in sght chmbr, clv prt, clv y-site 107 inch 272 cm, non-dehp.The complaint of a particle found within the fluid path on the primary plum set can be confirmed.An ftir (fourier-transform infrared spectroscopy) was done on the particulate found and no significant correlations were found.The probable cause and origin of the particulate is unknown.The lot history was reviewed and there were no non-conformances that would have contributed to the reported complaint.

• Brand Name: PRIMARY PLUM SET, 15 MICRON FILTER IN SIGHT CHAMBER, CLAVE SECONDARY PORT, CLAVE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• MDR Report Key: 8864994
• MDR Text Key: 153431783
• Report Number: 9615050-2019-00342
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Public: (01)(17)220301(10)4033470
• 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: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2022
• Device Catalogue Number: 140013190
• Device Lot Number: 4033470
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1