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 Codes	Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for evaluation- it has not been received.
Event or Problem Description
The event occurred on unknown date involving a microbore extension set - 5 inch, prepierced t-site where the customer reported that that they are having complications with some of their t-ports.They are concerned about a batch that seems to be malfunctioning which are also used for chemotherapy administrations.During one of their most recent chemotherapy administrations, the chemo solution leaked out and was coating the gloves of the handler, which becomes a hazard for their staff.They are beginning to track the lot numbers in hopes to confirm which batch of t-ports is bad, but right now they are suspecting lot # 11296752.17 of these t-ports have been removed from the work floor.There was patient involvement and unknown patient harm reported.
Additional Manufacturer Narrative
Additional information in d9.The complaint of leakage on the 126500490 could not be confirmed by investigation.No product samples, pictures, or videos were received for investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.The device history report (dhr) for lot 11296752 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: 18162214
• Report Number: 9615050-2023-00648
• Device Sequence Number: 6503985
• Product Code: FPA
• UDI-Device Identifier: 10887787005490
• UDI-Public: (01)10887787005490(17)251201(10)11296752
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2024

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: 12/01/2025
• Device Catalogue Number: 126500490
• Device Lot Number: 11296752
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2023
• Supplement Date Received by Manufacturer: 12/18/2023
• Initial Report FDA Received Date: 11/17/2023
• Supplement Report FDA Received Date: 04/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2022
• 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: UNSPECIFIED CHEMOTHERAPY, MRF UNK.
• Patient Sex: Unknown