MAUDE Adverse Event Report: MEDSOURCE LABS LLC BIOMEDIX; B31 SELEC-3 NIS LAS IV ADM SET

Model Number	B31-102
Medical Device Problem Code	Blocked Connection (2888)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user is experiencing resistance when attempting to push fluid through the injection site.

• Brand Name: BIOMEDIX
• Common Device Name: B31 SELEC-3 NIS LAS IV ADM SET
• Manufacturer (Section D): MEDSOURCE LABS LLC; 8600 shelby ct; chahassen MN 55317
• MDR Report Key: 22297698
• Report Number: 3003674698-2025-00982
• Device Sequence Number: 12918919
• Product Code: LHI
• UDI-Device Identifier: 00851470007057
• UDI-Public: 00851470007057
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K142097
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/20/2025

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 Model Number: B31-102
• Device Catalogue Number: B31-102
• Device Lot Number: B40711 AND B40959
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown