MAUDE Adverse Event Report: KURIN INC KURIN BLOOD CULTURE COLLECTION SET; BLOOD COLLECTION SET

Model Number	M-PIV12/MJ-PIV12
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2025
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.
Additional Manufacturer Narrative
Review of the product dhr did not turn up any nonconforming issues during manufacturing.Affected device was not returned for evaluation.No additional investigation could be conducted.The root cause was undetermined.

• Brand Name: KURIN BLOOD CULTURE COLLECTION SET
• Common Device Name: BLOOD COLLECTION SET
• Manufacturer (Section D): KURIN INC; 10840 thornmint rd; ste 111; san diego CA 92127
• Manufacturer (Section G): KURIN INC; 10840 thornmint rd; ste 111; san diego CA 92127
• Manufacturer Contact: neal hartman ; 10840 thornmint rd; ste 111; san diego, CA 92127 ; 8889639056
• MDR Report Key: 23663210
• Report Number: 3013696225-2025-00005
• Device Sequence Number: 10275354
• Product Code: JKA
• UDI-Device Identifier: 00857606008097
• UDI-Public: (01)00857606008097
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K162233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 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
• 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: White