MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY Y-TYPE BLOOD SET, 200 MICRON FILTER, PREPIERCED Y-SITE, SECURE LOCK, 80; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	142170488
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 date of event is unknown 01 jan 2024 has been used as a place holder.D4 h4 the lot#, expiration date, and manufacture date are unknown.E tab - the full facility name and location were not provided.Investigation summary no product samples, pictures, or videos were received for investigation.The complaint of blood tubing filtering the administration of antibiotics could not be confirmed by investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.A lot history review could not be conducted because no lot number(s) was/were identified.
Event or Problem Description
A complaint was received involving a primary y-type blood set, 200 micron filter, prepierced y-site, secure lock, 80 inch experienced occlusion.It was reported that the blood tubing filter was preventing/filtering the administration of antibiotics.There was unknown patient involvement and unknown adverse event.Additional information: iv antibiotics, iv tynenol, albumin, etc are frequently used with the tubing while normal saline or similar fluid is on the other portion of the y.

• Brand Name: PRIMARY Y-TYPE BLOOD SET, 200 MICRON FILTER, PREPIERCED Y-SITE, SECURE LOCK, 80
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 20603303
• Report Number: 9615050-2024-00809
• Device Sequence Number: 20680919
• Product Code: FPA
• UDI-Device Identifier: 10887787006435
• UDI-Public: 10887787006435
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K143087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/04/2024

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 Catalogue Number: 142170488
• 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: 10/05/2024
• Initial Report FDA Received Date: 11/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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