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 Problem Particulates (1451)

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

Event Date 04/08/2021

Event Type  malfunction  

Event Description

The event involved a secondary set, secure lock, with iv set hanger, 34 inch where a particulate inside the drip chamber was confirmed on the actual returned one device.The report stated that the particulate looks like it fell from the space between the wall of the drip chamber and the hole that allows the fluid to drip in the chamber.The issue was found by one of the nurses after spiking an iv bag.It was believed that cefazolin was infusing on the label.As received, there was an inch-long thin white particulate, black brown on one end inside the drip chamber.The drip chamber was cut open and the particle was free flowing inside the drip the chamber.An ft-ir was performed to identify origin of the particulate.There was a match to styrene/acrylonitrile.This material is similar to the material used to mold the white bag spike of the drip chamber.The probable cause of the material found in the drip chamber is most likely flash or particulate that fell off the bag spike during manufacturing in (b)(6).The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.There was no patient involvement and no adverse event.

• 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: 12021673
• MDR Text Key: 260227568
• Report Number: 9615050-2021-00087
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10887787006268
• UDI-Public: (01)10887787006268(17)231101(10)5048594
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2023
• Device Model Number: 1423028
• Device Catalogue Number: 142300490
• Device Lot Number: 5048594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2020
• 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