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

Catalog Number 126500490

Device Problem Fluid/Blood Leak (1250)

Patient Problems Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/01/2023

Event Type  malfunction  

Manufacturer Narrative

The device is available for evaluation- it has not been received.

Event 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.

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
• 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: 18162214
• MDR Text Key: 328643657
• Report Number: 9615050-2023-00648
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10887787005490
• UDI-Public: (01)10887787005490(17)251201(10)11296752
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142974
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 126500490
• Device Lot Number: 11296752
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2022
• 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
• Treatment: UNSPECIFIED CHEMOTHERAPY, MRF UNK.