MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. NDEHP PLUMSET 1CLAVE -SL; ADMINISTRATION SET

Model Number 1424228

Device Problem Particulates (1451)

Patient Problem No Patient Involvement (2645)

Event Date 03/01/2019

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned to the manufacturer for further evaluation but has not yet been received.

Event Description

It was reported that, on an unspecified date, a ¿speck¿ of something was noticed to be in the plastic of the drip chamber.The reporter stated, they could not tell if it is part of the plastic or if it is loose in the chamber.There was no patient involvement reported.No additional information is known at this time.

Manufacturer Narrative

The device involved in the event was not returned to the manufacturer for further evaluation.A batch record review was performed on the reported lot and no discrepancies that may have contributed to a complaint of this nature were found.The report was not confirmed.

• Brand Name: NDEHP PLUMSET 1CLAVE -SL
• Type of Device: ADMINISTRATION SET
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• MDR Report Key: 8504987
• MDR Text Key: 143944311
• Report Number: 9615050-2019-00107
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10887787006237
• UDI-Public: (01)10887787006237(17)210101(10)855205H
• 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,health
• Type of Report: Initial,Followup
• Report Date: 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2021
• Device Model Number: 1424228
• Device Catalogue Number: 142420489
• Device Lot Number: 855205H
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1