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

Device Problems Leak/Splash (1354); Patient-Device Incompatibility (2682)

Patient Problem Erythema (1840)

Event Date 05/14/2019

Event Type  Injury  

Event Description

Pt reported she had leaking at the end of only one hizentra infusion on (b)(6) 2019 but was able to finish the infusion, and reported redness that was probably caused by bandaid adhesive.We have shipped different tubing and bandaids to pt.No other info known.Reported to (b)(6).

• Brand Name: IV SCIG 26G 9MM FLO
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): REPRO-MED SYSTEMS, INC.
• MDR Report Key: 8739952
• MDR Text Key: 149621352
• Report Number: MW5087662
• 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: 06/10/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2019
• 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
• Patient Sequence Number: 1
• Patient Age: 20 YR