MAUDE Adverse Event Report: MEDEFIL NORMAL SALINE FLUSH; NORMAL SALIINE

Lot Number S15150

Device Problems Break (1069); Moisture or Humidity Problem (2986)

Patient Problems Pain (1994); Swelling (2091)

Event Date 03/17/2015

Event Type  Injury  

Event Description

Initially it took lot of force to flush the syringe which leads to severe pain and swelling on hand.Called 911 for help.Later it is found that the vessel got damaged because of the heavy fluid flow.

• Brand Name: NORMAL SALINE FLUSH
• Type of Device: NORMAL SALIINE
• Manufacturer (Section D): MEDEFIL
• MDR Report Key: 5029122
• MDR Text Key: 24098261
• Report Number: MW5055710
• Device Sequence Number: 1
• Product Code: NGT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Report Date: 08/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: S15150
• Was Device Available for Evaluation?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 49 YR