MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. NDEHP SAPPHIRE MIC NV +0.2FLTR; ACCESSORIES, PUMP, INFUSION

Model Number	1636202
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was discarded and is not available for investigation.Without a returned device a probable cause cannot be determined.
Event or Problem Description
The event involved a ndehp sapphire mic nv +.02fltr that the customer reported leaking an unknown chemotherapy medication from the filter area.There was patient involvement however no report of adverse event of a delay in therapy.This report captures the second of two devices.
Additional Manufacturer Narrative
No product samples, photos, or videos were returned for investigation.The complaint of leakage on the 163620455 could not be confirmed by investigation.No product samples, pictures, or videos were received for investigation.Without the return of the sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.The device history review (dhr) was reviewed and no non conformances were found that would have led to the complaint reported.

• Brand Name: NDEHP SAPPHIRE MIC NV +0.2FLTR
• Common Device Name: ACCESSORIES, PUMP, INFUSION
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• MDR Report Key: 9184511
• Report Number: 9615050-2019-00433
• Device Sequence Number: 16759203
• Product Code: MRZ
• UDI-Device Identifier: 10887787007357
• UDI-Public: (01)10887787007357(17)220501(10)4008547
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K171346
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2019

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: 05/01/2022
• Device Model Number: 1636202
• Device Catalogue Number: 163620455
• Device Lot Number: 4008547
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/19/2019
• Supplement Date Received by Manufacturer: 10/22/2019
• Initial Report FDA Received Date: 10/14/2019
• Supplement Report FDA Received Date: 11/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1