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

Device Problems Defective Component (2292); Improper Flow or Infusion (2954)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Spontaneous.Pt reported during last infusion one site appeared "clogged" and limited flow with his 2 needle sets that he infuses into.Pt reports he was able to finish the infusion by using connectors and infusing into a total of 3 sites with no concerns.Adv pt that needle sets are defective.No missed dose or ade reported; unknown if available for return; unknown if md aware.No further info provided.Unknown date of last use; we are sending new needle sets used to infuse hizentra at above dose/frequency.Reported to (b)(6) by pt/caregiver.

• Brand Name: IV SCIG 24G 12MM HIGH FLO NEEDLE SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): REPRO-MED SYSTEMS, INC., DBA KORU MEDICAL SYSTEMS
• MDR Report Key: 16294941
• MDR Text Key: 308914989
• Report Number: MW5114660
• 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: 01/23/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/02/2023
• Patient Sequence Number: 1
• Treatment: HIZENTRA
• Patient Sex: Male