MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY SET, 1 CLAVE Y-SITE, SECURE LOCK, 100 INCH; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	12661-01
Medical Device Problem Code	Free or Unrestricted Flow (2945)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2023
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
The event involved a primary set, 1 clave y-site, secure lock, 100 inch where it was reported malfunction/unstable drop continue regulator.The event was noted during use in patient.Product failure was at the clamp.No medical intervention and no blood loss.There was patient involvement, no patient harm and no delay in critical therapy.This is the first of five occurrences.
Additional Manufacturer Narrative
Received one (1) new 12661-01 primary set , 1 clave y-site, secure lock for inspection.No damages or anomalies noted.The set was primed according to packaging directions.There were no issues priming.Each of the clamps were engaged and flow stopped.When the clamps were disengaged flow continued.The set functioned according to product design.The reported complaint could not be replicated or confirmed.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 and no nonconformities were identified that may have contributed to the reported complaint device was returned on 9/21/2023.

• Brand Name: PRIMARY SET, 1 CLAVE Y-SITE, SECURE LOCK, 100 INCH
• 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: 17732201
• Report Number: 9615050-2023-00420
• Device Sequence Number: 6572295
• Product Code: FPA
• UDI-Device Identifier: 10887787005636
• UDI-Public: (01)10887787005636(17)260201(10)13487854
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2023

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: 02/01/2026
• Device Catalogue Number: 12661-01
• Device Lot Number: 13487854
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2023
• Supplement Date Received by Manufacturer: 10/12/2023
• Initial Report FDA Received Date: 09/12/2023
• Supplement Report FDA Received Date: 11/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2023
• 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