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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 24G 12MM HIGH FLO SET, ADMINISTRATION, INTRAVASCULAR

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REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS IV SCIG 24G 12MM HIGH FLO SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problem Material Twisted/Bent (2981)
Patient Problem Bruise/Contusion (1754)
Event Type  Injury  
Event Description
Patient states he received needle sets in last shipment - iv scig 24g 12mm high - which were a little bent and caused a little bruising and it has not happened with other lots before. Patient has 2 more sets with same lot number and those are available for return. Pt did not miss a dose. No further information provided. Indication: common variable immunodeficiency, unspecified needle set is used to infuse cuvitru 20% at above dose and frequency. Reported to (b)(6) by: patient/caregiver.
 
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Brand NameIV SCIG 24G 12MM HIGH FLO
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS
MDR Report Key11541752
MDR Text Key241924282
Report NumberMW5100158
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 07/06/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/19/2021
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
Is This a Reprocessed and Reused Single-Use Device?

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