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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 14MM HIGH-FLO SET, ADMINISTRATION, INTRAVASCULAR

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REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS IV++ SCIG 26G 14MM HIGH-FLO SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number RMS22614
Device Problems Difficult to Remove (1528); Physical Resistance/Sticking (4012)
Patient Problem Pain (1994)
Event Type  Injury  
Event Description
Patient reported that when she completes her infusion and tries to remove the needles(rms22614), the needles seem stuck in her body and she has a hard time taking them out. She has to pull hard to remove and it hurts. She states it is just the needle and the adhesive is already removed. No missed dose; unknown if needles available for return; unknown lot/ expiration. No further information known. Needles used to infuse hizentra 20% at above dose/ frequency. Reported to (b)(6) by patient/caregiver.
 
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Brand NameIV++ SCIG 26G 14MM HIGH-FLO
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS
MDR Report Key12475260
MDR Text Key271798074
Report NumberMW5103946
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 04/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberRMS22614
Device Catalogue NumberRMS22614
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
Is This a Reprocessed and Reused Single-Use Device?

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