MAUDE Adverse Event Report: KURIN, INC. KURIN PIV (PERIPHERAL INTRAVENOUS) CONNECTION, W/ BIOMERIEUX SHIELD; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Model Number	M-PIV12/MJ-PIV12
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The rn went to draw blood cultures on this patient.She got blood return in the kurin device, but no blood would flow through the filter, even when the bottle was attached to the vacutainer.

• Brand Name: KURIN PIV (PERIPHERAL INTRAVENOUS) CONNECTION, W/ 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: 20245720
• Report Number: 20245720
• Device Sequence Number: 7291599
• Product Code: JKA
• UDI-Device Identifier: 00857606008097
• UDI-Public: (01)00857606008097
• 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): 05/29/2024
• Report Date (Section F): 06/05/2024

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
• Device Model Number: M-PIV12/MJ-PIV12
• Device Lot Number: 622534493
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 09/18/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/18/2024
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 21 KG
• Date Report Sent to FDA: 06/05/2024