MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM Y-TYPE BLOOD SET, 200 MICRON FILTER, CLAVE SECONDARY PORT, CLAVE Y-; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	14220-01
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint/event involved a primary plum y-type blood set, 200 micron filter, clave secondary port, clave y-site, non-vented, secure lock, 110 inch.A crack on the device was reported that led to blood leakage.There was no report of human harm associated with this reported event/complaint.
Additional Manufacturer Narrative
No product samples, pictures, or videos were received for investigation.The complaint of 'crack on product resulted in blood leakage' 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.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.E1 initial reporter (full) phone number:(b)(6).

• Brand Name: PRIMARY PLUM Y-TYPE BLOOD SET, 200 MICRON FILTER, CLAVE SECONDARY PORT, CLAVE Y-
• 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: 19697106
• Report Number: 9615050-2024-00531
• Device Sequence Number: 8066619
• Product Code: FPA
• UDI-Device Identifier: 10887787002475
• UDI-Public: (01)10887787002475(17)260501(10)13605305
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K141789
• 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
• Type of Report: Initial
• Report Date (Section B): 07/08/2024

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: 05/01/2026
• Device Catalogue Number: 14220-01
• Device Lot Number: 13605305
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2023
• 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