MAUDE Adverse Event Report: REPRO-MED SYSTEMS, INC., DBA KORU MEDICAL SYSTEMS IV SCIG 26G 4MM HIGH FLO; SET, ADMINISTRATION, INTRAVASCULAR

Model Number RMS2-2604

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Spontaneous.Per pt's mom a particular lot number for needle set does not seem to work - lot n84080.No missed dose or ade reported; unknown if available for return; unknown if md aware.No further information provided.No side effects reported from defective product.No additional information available.Needle set used to infuse hizentra 20% at above dose/frequency.Indication: antibody deficiency with near-normal immunoglobulins or with hyperimmunoglobulinemia.Reported to (b)(6) by pt/caregiver.

• Brand Name: IV SCIG 26G 4MM HIGH FLO
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): REPRO-MED SYSTEMS, INC., DBA KORU MEDICAL SYSTEMS
• MDR Report Key: 16379535
• MDR Text Key: 309674437
• Report Number: MW5114943
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• 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: 02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 02/01/2024
• Device Model Number: RMS2-2604
• Device Lot Number: N84080
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/14/2023
• Patient Sequence Number: 1
• Patient Sex: Female