MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. MICROBORE EXTENSION SET - 5 INCH, PREPIERCED T-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	126500490
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A facility submitted a medsun mandatory medwatch report (uf/importer report# (b)(4)) regarding a microbore extension set - 5 inch, prepierced t-site.The customer reported that the t-site was noted to be leaking intravenous (iv) fluids in the neonatal intensive care unit (nicu).The device is a single-use device that was not reprocessed and reused on a patient.The original intended procedure is a connection site for peripherally inserted central catheter (picc) and iv fluids.No hole, cut, tears or any defect noted.No blood loss or bleed back was noted, and tubing was replaced.The tubing was set up as a t-connector for peripheral arterial line and the leak occurred at the puncture site.There was patient involvement and no patient harm.This is the first of three reports.
Additional Manufacturer Narrative
The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.

• Brand Name: MICROBORE EXTENSION SET - 5 INCH, PREPIERCED T-SITE
• Common Device Name: 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: 17395914
• Report Number: 9615050-2023-00266
• Device Sequence Number: 20347299
• Product Code: FPA
• UDI-Device Identifier: 10887787005490
• UDI-Public: (01)10887787005490(17)241101(10)5634770
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K142974
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/11/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/01/2024
• Device Catalogue Number: 126500490
• Device Lot Number: 5634770
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NORMAL SALINE, MFR UNK
• Patient Sex: Unknown