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	09/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Rn opened kurin blood culture collection set and attachment device was found to be shattered w/ [with] the needle collection system exposed and posed potential for a needle stick.

• 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: 23356495
• Report Number: 23356495
• Device Sequence Number: 8872008
• 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): 09/30/2025
• Report Date (Section F): 09/30/2025

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: M-PIV12/MJ-PIV12
• Device Lot Number: 8714-032725-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/22/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/22/2025
• 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 Sex: Unknown
• Date Report Sent to FDA: 09/30/2025