MAUDE Adverse Event Report: EXCELSIOR MEDICAL LLC NORMAL SALINE FLUSH 10ML/10ML; SALINE, VASCULAR ACCESS FLUSH

Lot Number 3132283

Device Problem Device Emits Odor (1425)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/04/2018

Event Type  Injury  

Event Description

Pt flushed central line with excelsior brand flush and reported a skunk taste.Dose or amount: 10 ml, frequency: ud, route: iv.Dates of use: (b)(6) 2018; diagnosis or reason for use: cvc maintenance.Event abated after use stopped or dose reduced? yes, event reappeared after reintroduction? doesn't apply.(b)(4).

• Brand Name: NORMAL SALINE FLUSH 10ML/10ML
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): EXCELSIOR MEDICAL LLC
• MDR Report Key: 7752652
• MDR Text Key: 116354999
• Report Number: MW5078882
• 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: 07/24/2018

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?: No
• Device Operator: No Information
• Device Expiration Date: 01/01/2020
• Device Lot Number: 3132283
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/03/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 28 YR
• Patient Weight: 53