MAUDE Adverse Event Report: NURSE ASSIST, LLC SALINE, VASCULAR ACCESS FLUSH

Patient Problems Purulent Discharge (1812); Fever (1858); Hemorrhage/Bleeding (1888); Unspecified Infection (1930)

Event Date 10/21/2023

Event Type  Injury  

Event Description

My wife received several serious dog bites to her leg.I was a medic in the army and still carry a trauma kit.I used "nurse assist dermatitis sterile saline 100ml" to irritate the wounds before placing pressure dressings to the wounds.My wife was bleeding very badly and bled through a military dressing before we reached the emergency room.Within 2-3 days she became feverish and the wounds went south quickly, turning greenish and oozing staggering amounts of pus.We visited the er again, then followed up with our family practitioner two additional times.My wife had to receive iv antibiotics as well as two rounds of increasingly strong oral antibiotics.Because of the infection, her wounds have been slow to heal and i feel certain the saline was the culprit.

• Brand Name: SALINE, VASCULAR ACCESS FLUSH
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): NURSE ASSIST, LLC
• MDR Report Key: 18536988
• MDR Text Key: 333398027
• Report Number: MW5150502
• 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: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: SODIUM CHLORIDE.
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 56 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White