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

Device Problem Particulates (1451)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/23/2023

Event Type  malfunction  

Manufacturer Narrative

The device was received for evaluation.The investigation is still pending.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 321655194
• Report Number: 9615050-2023-00343
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10887787005339
• UDI-Public: (01)10887787005339(17)260201(10)13487857
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151969
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: TOTAL PARENTERAL NUTRITION, MFR UNK.