MAUDE Adverse Event Report: KURIN, INC. KURIN 21 GAUGE, PUSH BUTTON NEEDLE W/12 TUBING, BIOMERIEUX SHIELD; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Model Number	M-21221/MJ-221
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Patient needed 2nd set of blood cultures, straight stick 21g kurin set obtained to draw, after puncturing the vein blood was coming out of the kurin filter reservoir itself instead of stopping after filling leaking on the patient.

• Brand Name: KURIN 21 GAUGE, PUSH BUTTON NEEDLE W/12 TUBING, BIOMERIEUX SHIELD
• Common Device Name: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): KURIN, INC.; 10840 thornmint road; suite 111; san diego CA 92127
• MDR Report Key: 19339763
• Report Number: 19339763
• Device Sequence Number: 18314749
• Product Code: JKA
• UDI-Device Identifier: 00857606008073
• UDI-Public: (01)00857606008073
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/21/2024
• Report Date (Section F): 02/21/2024

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 Model Number: M-21221/MJ-221
• Device Lot Number: 8026-031723-01
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/17/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/17/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Sex: Male
• Date Report Sent to FDA: 02/21/2024