MAUDE Adverse Event Report: REPRO-MED SYSTEMS, INC. IV SCIG 36" 27G 9MM, SUB-320; SET, ADMINISTRATION, INTRAVASCULAR

Device Problems Leak/Splash (1354); Unexpected Therapeutic Results (1631)

Patient Problems Local Reaction (2035); Skin Inflammation (2443)

Event Type  Injury  

Event Description

Pt was sent rms needles instead of emed (possibly because of stock issue).Pt stated there was some blood during drawback, and a little leaking causing some local redness.When trying to re-insert needle.Rph advised pt to use different needle set when this occurs.Pt understood.No missed doses occurred.No other info known.Reported to (b)(6).

• Brand Name: IV SCIG 36" 27G 9MM, SUB-320
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): REPRO-MED SYSTEMS, INC.
• MDR Report Key: 8650904
• MDR Text Key: 146497696
• Report Number: MW5086966
• 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: 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1