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	11/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.
Event or Problem Description
The event occurred on an unspecified date and involved a microbore extension set - 5 inch, prepierced t-site.It was reported that all port sides are leaking.There was patient involvement and no adverse event or patient harm.
Additional Manufacturer Narrative
Received one (1) new 126500490 microbore extension set for inspection.No damages or anomalies noted.The set was leak tested per product specifications.There was no leakage.The reported complaint of leakage could not be confirmed.Without the return of the used sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.The device history record for lot 13518314 was reviewed and no non conformities were found that would have led to the reported complaint.

• 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: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 18253344
• Report Number: 9615050-2023-00699
• Device Sequence Number: 7191514
• Product Code: FPA
• UDI-Device Identifier: 10887787005490
• UDI-Public: (01)10887787005490(17)260301(10)13518314
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2026
• Device Catalogue Number: 126500490
• Device Lot Number: 13518314
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2023
• Supplement Date Received by Manufacturer: 01/31/2024
• Initial Report FDA Received Date: 12/02/2023
• Supplement Report FDA Received Date: 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2023
• 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
• Patient Sex: Unknown