MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, CLAVE SECONDARY PORT, 2 CLAVE Y-SITES, 0.2 MICRON FILTER, SECU; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 142540489

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 11/07/2023

Event Type  malfunction  

Manufacturer Narrative

The device is available to be returned for evaluation; however, it has not yet been received.F2 medwatch number: mw5148054.

Event Description

The event involved a primary plum set, clave secondary port, 2 clave y-sites, 0.2 micron filter, secure lock, 112 inch where it was reported there was a red colored tainted color inside sterile intravenous tubing.The issue was noted when putting spike into bag, it was noted during initial set-up/priming.This is a single-use device that was not reprocessed on a patient.The event did not occur while the product was in use with a patient.There was no adverse event or delay in critical therapy.

Manufacturer Narrative

The reported complaint of red colored tubing was not confirmed.No samples or pictures or videos were returned for evaluation.Without the return of the reported sample, the complaint could not be confirmed.The lot history was reviewed and no commodities were identified that would lead to the reported complaint.Updated information in d9.

• Brand Name: PRIMARY PLUM SET, CLAVE SECONDARY PORT, 2 CLAVE Y-SITES, 0.2 MICRON FILTER, SECU
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 18410844
• MDR Text Key: 331522934
• Report Number: 9615050-2023-00816
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10887787006039
• UDI-Public: (01)10887787006039(17)260501(10)13588490
• 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,User Facility,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 142540489
• Device Lot Number: 13588490
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2023
• Initial Date FDA Received: 12/28/2023
• Supplement Dates Manufacturer Received: 01/09/2024
• Supplement Dates FDA Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2023
• 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