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

Model Number	1424228
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned to the manufacturer for further evaluation but has not yet been received.
Event or Problem 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.
Additional 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
• Common Device Name: ADMINISTRATION SET
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• MDR Report Key: 8504987
• Report Number: 9615050-2019-00107
• Device Sequence Number: 1516279
• Product Code: FPA
• UDI-Device Identifier: 10887787006237
• UDI-Public: (01)10887787006237(17)210101(10)855205H
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K141789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2019

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 03/22/2019
• Supplement Date Received by Manufacturer: 05/20/2019
• Initial Report FDA Received Date: 04/11/2019
• Supplement Report FDA Received Date: 06/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1