MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY SET, PIGGYBACK WITH BACKCHECK VALVE, 2 CLAVE Y-SITES, 0.2 MICRON FILTER,; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	20669-01
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a primary set, piggyback with backcheck valve, 2 clave y-sites, 0.2 micron filter, secure lock, 100 inch generated a leak during patient use.Upon using the set, found some were defective, resulting in inadequate quantity to use." quantity affected are 15 and it is unknown if it is available for return.The customer also stated that it is a product quality complaint, manufacturing-related and not an adverse event.A sample picture is not provided since they already disposed of the defective intravenous (iv) sets.The reporter/user is willing to be further contacted.There was no harm to the patient reported.
Additional Manufacturer Narrative
No product samples, pictures, or videos were received for investigation.The complaint of leakage could not be confirmed by investigation.No product samples, pictures, or videos were received for 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.

• Brand Name: PRIMARY SET, PIGGYBACK WITH BACKCHECK VALVE, 2 CLAVE Y-SITES, 0.2 MICRON FILTER,
• 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: 19244095
• Report Number: 9615050-2024-00358
• Device Sequence Number: 12619974
• Product Code: FPA
• UDI-Device Identifier: 10887787005926
• UDI-Public: (01)10887787005926(17)250901(10)6486734
• 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
• Report Date (Section B): 05/03/2024

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: 09/01/2025
• Device Catalogue Number: 20669-01
• Device Lot Number: 6486734
• 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: 02/28/2024
• Initial Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED FLUID, UNK MFR.
• Patient Sex: Unknown