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

Catalog Number	163620455
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event occurred on an unspecified date and involved a ndehp sapphire mic nv +0.2fltr.It was reported a leak occurred from one of the small perforations on the in-line filter.There was patient involvement and there was no patient harm-as per the oncology pharmacist, the medication also leaked onto the patient's t-shirt, no skin irritation was reported.The patient was advised to throw that t-shirt in the garbage.The team was wearing ppe for this intervention.
Additional Manufacturer Narrative
The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.

• 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
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 18862904
• Report Number: 9615050-2024-00217
• Device Sequence Number: 3326046
• Product Code: MRZ
• UDI-Device Identifier: 10887787007357
• UDI-Public: (01)10887787007357(17)240301(10)5209968
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K171346
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/07/2024

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: 03/01/2024
• Device Catalogue Number: 163620455
• Device Lot Number: 5209968
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2024
• Initial Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown