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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: REPRO-MED SYSTEMS, INC., DBA KORU MEDICAL SYSTEMS IV SCIG 26G 9MM HIGH FLO SET, ADMINISTRATION, INTRAVASCULAR

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REPRO-MED SYSTEMS, INC., DBA KORU MEDICAL SYSTEMS IV SCIG 26G 9MM HIGH FLO SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Inflammation (1932)
Event Type  Injury  
Event Description
Spontaneous pt requested to have 6mm needle set as "knots" have been more of an issue with the use of the 9mm needle set; no further info. Reported to (b)(6) by pt/caregiver.
 
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Brand NameIV SCIG 26G 9MM HIGH FLO
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
REPRO-MED SYSTEMS, INC., DBA KORU MEDICAL SYSTEMS
MDR Report Key12049697
MDR Text Key258065092
Report NumberMW5102028
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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