MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. NDHP 0.2 MICRN HP CL; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	2066828
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	08/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for evaluation.Without the return of the sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.
Event or Problem Description
The event occurred on an unknown date involving an extension set, 17 inch, 0.2 micron filter, clave(tm) y-site, secure lock where it was leaking of an unspecified chemo drugs at the filter and it came in contact with the patient¿s hand.The customer also stated that they could not see if the filter cracked, and this happened numerous times.The issue was noticed during infusion at approximately 12 hours post to the start of infusion.When asked if there was medical intervention required, it was mentioned that they need to get a new bag of chemo with new tubing and restart the infusion, so the infusion was paused during this time.There was patient involvement but no report of human harm.This is the first of two events.
Additional Manufacturer Narrative
Received photo from customer showing the 0.2 micron filter from the 206680428 ndhp 0.2 micrn hp cl.The filter vents were circled.No damages or anomalies observed.The reported complaint of leakage could not be confirmed from the photo provided.Without the return of the used sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.

• Brand Name: NDHP 0.2 MICRN HP CL
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 15459816
• Report Number: 9615050-2022-00210
• Device Sequence Number: 6005972
• Product Code: FPA
• UDI-Device Identifier: 10887787005919
• UDI-Public: (01)10887787005919(17)241101(10)5633749
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K151969
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2022

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: 11/01/2024
• Device Model Number: 2066828
• Device Catalogue Number: 206680428
• Device Lot Number: 5633749
• 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: 08/22/2022
• Supplement Date Received by Manufacturer: 10/07/2022
• Initial Report FDA Received Date: 09/20/2022
• Supplement Report FDA Received Date: 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED CHEMOTHERAPY, MFR UNK
• Patient Sex: Unknown