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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
Model Number RMS4-2609
Device Problem Failure to Deliver (2338)
Patient Problems Discomfort (2330); Sleep Dysfunction (2517); Abdominal Distention (2601)
Event Type  Injury  
Event Description
Indication: selective deficiency of immunoglobulin g [igg] subclasses spontaneous call. Patient called in and stated that last infusion needle set somehow malfunctioned and only 1 or 2 sites were infused on one side and the patient usually watches tv and did not notice until infusion was complete. That night the distention caused a lot of discomfort and difficult to sleep. Pt did not miss a dose; unknown if needle set is available for return; lot/expiration unknown. No further information known. Needle set is used to infuse gamunex-c 10% as above.
 
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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 Key10559689
MDR Text Key207902861
Report NumberMW5096750
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 08/31/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberRMS4-2609
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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