MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. NDEHP PLUMSET 2CLAVES-SL; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 1468728

Device Problems Particulates (1451); Device Contamination with Chemical or Other Material (2944)

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

Event Date 05/12/2022

Event Type  malfunction  

Event Description

The event involved a ndehp plumset 2claves-sl in which the customer reported that the nurse found debris (black particles inside cassette of tubing set) upon taking out of package.The tubing was sequestered; there was no patient involvement and no harm reported as a consequence of this event.

Manufacturer Narrative

The device has been received for evaluation, however, investigation is not yet complete.Possible lot numbers (plots): 5696119 - manufacture date: 12/1/2021 - expiration date: 12/1/2024 and 5696123 - manufacture date 12/1/2021 - expiration date 12/1/2024.

Manufacturer Narrative

One used list #146870489, primary plum set, clave secondary port, clave y-site, secure lock, 103 inch; lot #unknown was receive for evaluation.The event related to black particles inside cassette of tubing set was confirmed.An assessment was carried out in the cassette area to determine if it is possible that during the cassette assembly process, grease particles could be produced on the silicone diaphragm.The cut piece of the cassette was examined, and several black particles could be observed.This piece was disassembled, and the black particles were found to be grease.During the molding process, the tools use grease as lubricant, there is a possibility that these small particles of grease may have fallen off on the diaphragm.Lot history review was performed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: NDEHP PLUMSET 2CLAVES-SL
• 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: 14605510
• MDR Text Key: 293450397
• Report Number: 9615050-2022-00111
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1468728
• Device Catalogue Number: 146870489
• Device Lot Number: PLOTS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2022
• Date Manufacturer Received: 08/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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