MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - NORTHFIELD SODIUM CHLORIDE 0.9% FLUSH; SALINE, VASCULAR ACCESS FLUSH

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 07/31/2023

Event Type  Injury  

Event Description

Patient broke out in hives at the end of her infusion of ivig.Hives spread out all over her limbs, torso and neck (aside from hands and feet).She took oral diphenhydramine and the reaction went away after about 2 hours.The reaction could be attributed to the ivig product, saline flush or heparin flush.Reference report #mw5145360.

• Brand Name: SODIUM CHLORIDE 0.9% FLUSH
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - NORTHFIELD
• MDR Report Key: 17710497
• MDR Text Key: 323072173
• Report Number: MW5145359
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 09/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/07/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GAMUNEX-C 10%
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 107 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White