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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KURIN, INC. KURIN BLOOD COLLECTION SET; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
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KURIN, INC. KURIN BLOOD COLLECTION SET; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION Back to Search Results
Model Number NONE
Device Problems Retraction Problem (1536); Material Protrusion/Extrusion (2979); Sharp Edges (4013); Fail-Safe Did Not Operate (4046)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/23/2023
Event Type  malfunction  
Event Description
When drawing blood, the advanced safety needle is not fully retracting; post collection the sheath does not cover the needle entirely leaving the tip of the needle exposed.Potential for a needlestick.Manufacturer response for blood collection needle, (brand not provided) (per site reporter).The vice president of sales was informed, there is no identifying information, lot #, serial #, etc.The response from the vp was to take all of the kurin stock away and would be sending new product with the old bd needle.
 
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Brand Name
KURIN BLOOD COLLECTION SET
Type of Device
TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
Manufacturer (Section D)
KURIN, INC.
10840 thornmint road suite 111
san diego CA 92127
MDR Report Key16452036
MDR Text Key310335540
Report Number16452036
Device Sequence Number1
Product Code JKA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/12/2023
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 Operator Other
Device Model NumberNONE
Device Catalogue NumberNONE
Device Lot NumberNONE
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/12/2023
Event Location Hospital
Date Report to Manufacturer02/28/2023
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/28/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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