MAUDE Adverse Event Report: REPRO-MED SYSTEMS, INC., DBA KORU MEDICAL SYSTEMS TUBING FREEDOM 60 24" EXT; SET, ADMINISTRATION, INTRAVASCULAR

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Indication; common variable immunodeficiency, unspecified.Spontaneous: per patient, was in the process of infusion the tubing broke and caused the medication to leak and member did not get any medication.No other specifics regarding defective device.Member requests next day delivery for saturday of the wasted vial of gamunex-c and tubing so that she can complete her dose; no adverse events reported; unknown if device available for return; unknown lot number.No further information known.Reported to (b)(6) by pt/caregiver.

• Brand Name: TUBING FREEDOM 60 24" EXT
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): REPRO-MED SYSTEMS, INC., DBA KORU MEDICAL SYSTEMS
• MDR Report Key: 12482054
• MDR Text Key: 272308545
• Report Number: MW5104024
• 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
• Type of Report: Initial
• Report Date: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/07/2022
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1