MAUDE Adverse Event Report: REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS IV SCIG 26G 9MM HIGH FLO; SET, ADMINISTRATION, INTRAVASCULAR

Model Number RMS4-2609

Device Problem Failure to Deliver (2338)

Patient Problems Discomfort (2330); Sleep Dysfunction (2517); Abdominal Distention (2601)

Event Type  Injury  

Event Description

Indication: selective deficiency of immunoglobulin g [igg] subclasses spontaneous call.Patient called in and stated that last infusion needle set somehow malfunctioned and only 1 or 2 sites were infused on one side and the patient usually watches tv and did not notice until infusion was complete.That night the distention caused a lot of discomfort and difficult to sleep.Pt did not miss a dose; unknown if needle set is available for return; lot/expiration unknown.No further information known.Needle set is used to infuse gamunex-c 10% as above.

• Brand Name: IV SCIG 26G 9MM HIGH FLO
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS
• MDR Report Key: 10559689
• MDR Text Key: 207902861
• Report Number: MW5096750
• 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: 08/31/2020

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
• Device Model Number: RMS4-2609
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/18/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1