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	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for investigation.Without the return of the device, a probable cause is unable to be determined.
Event or Problem Description
It was reported that a primary plum y-type blood set generated a ¿filter crack".There was no patient harm reported.There is no additional information available at this time.

• 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: 17662368
• Report Number: 9615050-2023-00371
• Device Sequence Number: 15014419
• Product Code: FPA
• UDI-Device Identifier: 10887787002475
• UDI-Public: (01)10887787002475(17)250601(10)5935506
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/09/2023

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: 06/01/2025
• Device Catalogue Number: 14220-01
• Device Lot Number: 5935506
• 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: 08/09/2023
• Initial Report FDA Received Date: 08/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2022
• 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