MAUDE Adverse Event Report: REPRO-MED SYSTEMS, INC., DBA RMS MEDICAL PRODUCTS IV SCIG 26G 12MM HIGH FLO; SET, ADMINISTRATION, INTRAVASCULAR

Device Problem Failure to Infuse (2340)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/15/2019

Event Type  malfunction  

Event Description

Spontaneous call from pt - reported that when they tried to infuse medication with the iv scig.It did not infuse.Pt advised that the "part was faulty" and did not provide any further detail.Pt did not experience any adverse event and did not report any missed doses.Unk if product is on hand.Indication: chronic inflammatory demyelinating polyneuritis.Reported to (b)(6) to pt/caregiver.

• Brand Name: IV SCIG 26G 12MM HIGH FLO
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): REPRO-MED SYSTEMS, INC., DBA RMS MEDICAL PRODUCTS
• MDR Report Key: 8473677
• MDR Text Key: 140751305
• Report Number: MW5085486
• 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: 03/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 57 YR