MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY SET, 3 CLAVE Y-SITES, 100 INCH, NON-DEHP; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	B91260490
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for investigation as the customer has discarded it.Without the return of the device, a probable cause is unable to be determined.If additional information or if a device later becomes available, supplemental vigilance report(s) will be submitted at that time.Initial reporter full phone no: (b)(6).
Event or Problem Description
The complaint/event occurred on an unspecified date and involved a primary set, 3 clave y-sites, 100 inch, non-dehp.The reported stated that the tubing of the device was leaking.There was no human harm reported as a result of this complaint/event.
Additional Manufacturer Narrative
The device history record was reviewed and no non-conformities were identified that would have led to the reported complaint.
Event or Problem Description
The complaint was updated on 13-mar-2024 indicating that the leak was located at the plastic where the "convertible piercing pin" joins the "filter vent cover." the complaint/issue occurred in the main operating room at the facility.

• Brand Name: PRIMARY SET, 3 CLAVE Y-SITES, 100 INCH, NON-DEHP
• 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: 18314955
• Report Number: 9615050-2023-00773
• Device Sequence Number: 6643684
• Product Code: FPA
• UDI-Device Identifier: 10887787009306
• UDI-Public: (01)10887787009306(17)251101(10)11269960
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K142367
• 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): 03/19/2024

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: 11/01/2025
• Device Catalogue Number: B91260490
• Device Lot Number: 11269960
• 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: 11/20/2023
• Supplement Date Received by Manufacturer: 03/13/2024
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 03/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2022
• 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