MAUDE Adverse Event Report: MEDEFIL MEDEFIL SALINE IV FLUSH

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Nausea (1970); Vomiting (2144); Burning Sensation (2146); Palpitations (2467)

Event Date 11/09/2015

Event Type  Injury  

Event Description

When changing infusion pharmacies, my saline flush syringes i use for my picc line were changed from the bd posiflush (which worked great) to: medefil, inc normal saline iv flush syringe 10ml immediately and every time i flush with these flushes i get very sick, nausea, my heart rate increases drastically, and i throw up, i get a metallic taste in my mouth, and my throat burns horrible and i get a very strange and unpleasant taste/smell sensation.I have some of the bd posiflush left so that next time i flushed i tried one of those again and it did not cause the same result.Something is wrong with the medefil, inc normal saline iv flush syringes.I am contacting my infusion pharmacy to request the bd posiflush brand.I tested it several times and it's this brand of flush causing the problems.

• Brand Name: MEDEFIL SALINE IV FLUSH
• Type of Device: SALINE IV FLUSH
• Manufacturer (Section D): MEDEFIL
• MDR Report Key: 5221827
• MDR Text Key: 31196025
• Report Number: MW5057843
• Device Sequence Number: 1
• Product Code: FOZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/09/2015

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?: Yes
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/09/2015
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Weight: 84