MAUDE Adverse Event Report: REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS IV SCIG 24G 12MM HIGH FLO; SET, ADMINISTRATION, INTRAVASCULAR

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.

• Brand Name: IV SCIG 24G 12MM HIGH FLO
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS
• MDR Report Key: 11541752
• MDR Text Key: 241924282
• Report Number: MW5100158
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): Y
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/19/2021
• Patient Sequence Number: 1