MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, SECURE LOCK, 103 INCH; 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 02/06/2023

Event Type  malfunction  

Event Description

The event involved a primary plum set, clave secondary port, clave y-site, secure lock, 103 inch in which the customer reported that foreign matter was observed in the drip chamber.It was not reported that if there was patient involvement; no harm was reported as a consequence of this event.

Manufacturer Narrative

The device is expected to be returned for evaluation, however, it is yet to be received.Initial reporter- ext.(b)(4).

Manufacturer Narrative

One used device was returned for evaluation on 3/20/23.As received, a black spot was confirmed visible in the drip chamber.The drip chamber was cut open and the particle was confirmed to be embedded in the drip chamber wall, not in the fluid path.The area of the particle failed the allowable surface area of embedded material.The reported complaint can be confirmed.The most probable cause is burnt material embedded in the wall of the drip chamber during the molding process.The embedded material is not in the fluid path, and does not affect the functionality of the device.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, SECURE LOCK, 103 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: 16494798
• MDR Text Key: 310899622
• Report Number: 9615050-2023-00052
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10887787005650
• UDI-Public: (01)10887787005650(17)250801(10)6358756
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K141789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2023
• 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: 14687-15
• Device Lot Number: 6358756
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2022
• 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