MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. SECONDARY SET, SECURE LOCK, WITH IV SET HANGER, 34 INCH; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 1423028

Device Problems Contamination (1120); Particulates (1451)

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

Event Date 06/22/2023

Event Type  malfunction  

Manufacturer Narrative

The device is not available for investigation, however photos were provided.Investigation pending.

Event Description

The event involved a secondary set, secure lock, with iv set hanger, 34 inch where it was reported that a secondary set that had debris in it before it was used.The product was open for no longer than 5 minutes and the particulate was noted first in the original icu-medical container.No patient involved and no patient harm.

Manufacturer Narrative

A photo of the packaging and the drip chamber was returned.There appeared to be dark spots on the drip chamber typical of burnt embedded material.The reported complaint on the 142300490 secondary set can be confirmed.The most probable cause is burnt material embedded in the wall of the drip chamber during the molding process in costa rica.It is typically embedded in the wall and not in the fluid path.The device history record for lot 5785993 was reviewed and no non conformities were found that would have led to the reported complaint.

• Brand Name: SECONDARY SET, SECURE LOCK, WITH IV SET HANGER, 34 INCH
• 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: 17277473
• MDR Text Key: 319394268
• Report Number: 9615050-2023-00227
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142367
• 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: 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1423028
• Device Catalogue Number: 142300490
• Device Lot Number: 5785993
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2022
• 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