MAUDE Adverse Event Report: EXCELSIOR MEDICAL LLC 0.9 PERCENT SODIUM CHLORIDE INJECTION USP; SALINE, VASCULAR ACCESS FLUSH

Lot Number 3131591

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 05/27/2018

Event Type  malfunction  

Event Description

Preparing to use zr saline flush overwrap bar code scanned as heparin flush.Interior bar code scanned appropriately as 0.9 percent sodium chloride.Dose or amount: 5 ml millilitres.

• Brand Name: 0.9 PERCENT SODIUM CHLORIDE INJECTION USP
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): EXCELSIOR MEDICAL LLC
• MDR Report Key: 7564988
• MDR Text Key: 110182858
• Report Number: MW5077604
• 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: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/01/2019
• Device Lot Number: 3131591
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/01/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1