MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. EXTENSION SET, 15 INCH, 1.2 MICRON FILTER, CLAVE(TM) Y-SITE, SECURE LOCK; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	123540451
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received for evaluation.The investigation is still pending.
Event or Problem Description
The event involved an extension set, 15 inch, 1.2 micron filter, clave(tm) y-site, secure lock where it was reported that there was condensation inside the tube and that it has white residue.The event occurred during set up (although patient reported this has happened previously as well with dates unknown).Additionally, the product was stored in a controlled temperature/humidity warehouse with continuous monitoring, protected from light.The medication involved was a total parenteral nutrition (tpn).There was no patient harm reported and no delay in therapy.
Additional Manufacturer Narrative
Received two used 123540451 extension set, 1.2 micron filter.Splay was observed around the gate typical of a molding error.The discoloration is cosmetic and does not affect the functionality of the device.The reported complaint of condensation in the tubing could not be confirmed.The discoloration is typical of a molding error.The lot history of the provided labels were reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: EXTENSION SET, 15 INCH, 1.2 MICRON FILTER, CLAVE(TM) Y-SITE, SECURE LOCK
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17596076
• Report Number: 9615050-2023-00343
• Device Sequence Number: 7420813
• Product Code: FPA
• UDI-Device Identifier: 10887787005339
• UDI-Public: (01)10887787005339(17)260201(10)13487857
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K151969
• 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): 07/25/2023

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: 123540451
• Device Lot Number: 13487857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2023
• Supplement Date Received by Manufacturer: 09/08/2023
• Initial Report FDA Received Date: 08/22/2023
• Supplement Report FDA Received Date: 09/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TOTAL PARENTERAL NUTRITION, MFR UNK.
• Patient Sex: Unknown