MAUDE Adverse Event Report: REPRO MED SYSTEMS, INC. IV++ SCIG 26G 14MM HIGH FLO; SET, ADMINISTRATION, INTRAVASCULAR

Model Number RMS32614

Device Problem Leak/Splash (1354)

Patient Problems Headache (1880); Itching Sensation (1943); Pain (1994); Cough (4457); Unspecified Respiratory Problem (4464); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Indication: selective deficiency of immunoglobulin g [lgg] subclasses.Patient reported leaking sometimes during infusion and sometimes afterward.She is already using the longest needle size at 14mm, and does not want to increase the number of sites either.No adverse event reported; unknown if needles available for return; unknown if md aware.No further information provided.Pt also reports stomach/flank pain, coughing during and/or after infusion, phlegm build up, headaches, itching, bright red welts at infusion sites.These symptoms are irregular and no specific pattern of when she experiences them.Needles used to infuse cutaquig at above dose and frequency.Reported to (b)(6)/caremark by pt/caregiver.

• Brand Name: IV++ SCIG 26G 14MM HIGH FLO
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): REPRO MED SYSTEMS, INC.
• MDR Report Key: 14357256
• MDR Text Key: 291489739
• Report Number: MW5109615
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• 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: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 04/11/2023
• Device Model Number: RMS32614
• Device Catalogue Number: RMS32614
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Sex: Female