MAUDE Adverse Event Report: MEDEFIL INC. SODIUM CHLORIDE 0.9% FLUSH ; SALINE, VASCULAR ACCESS FLUSH

Lot Number S19258

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Burning Sensation (2146); Reaction (2414)

Event Date 07/24/2019

Event Type  Injury  

Event Description

Infusion rn, called to review apparent reaction to ns flush.She reports no difficulty with obtaining iv access, priming line, blood return, etc.Upon flushing the line with ns flush provided in most recent shipment, (lot #s19258, exp 04/2021) she reports pt experienced burning.Rn then changed iv access site, again with excellent blood return, upon flushing, with same lot of ns flush, pt again had burning and pain.Rn, then without pt being made aware, changed access again, used ns flush of a different lot, previously in the home (lot# s19224, exp 03/2021), pt had no problem.Rn reports she has never seen this happen in her experience with a pt in over 20 years.She reports she has adequate ns flush of the non-irritating lot (lot #s19224, exp 03/2021) in the home for next infusion.Iv access for fabrazyme infusions.

• Brand Name: SODIUM CHLORIDE 0.9% FLUSH
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): MEDEFIL INC.
• MDR Report Key: 8865548
• MDR Text Key: 153680149
• Report Number: MW5088793
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 6425311130
• UDI-Public: 6425311130
• Combination Product (y/n): Y
• 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: 08/02/2019
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 04/01/2021
• Device Lot Number: S19258
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 10 YR
• Patient Weight: 30