MAUDE Adverse Event Report: BD BD POSIFLUSH IV SALINE; SALINE, VASCULAR ACCESS FLUSH

Lot Number 7081704

Device Problem Device Emits Odor (1425)

Patient Problem Headache (1880)

Event Date 07/27/2017

Event Type  malfunction  

Event Description

Bd posi prefilled flush saline was used to flush in catheter pre-dialysis.The pt reported within 20 seconds a harsh chemical taste and smell in her throat and behind her nasal area.She does not have this reaction to normal iv bag saline only the prefilled version.She got a headache.Strength: 0.9% percent, dose or amount: 10 mg/ml - milligrams per millilitres, frequency: other, route: intra-arterial.Diagnosis or reason for use: pre and post catheter for dialysis.

• Brand Name: BD POSIFLUSH IV SALINE
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BD
• MDR Report Key: 6773123
• MDR Text Key: 82137911
• Report Number: MW5071410
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 8290306546
• UDI-Public: 8290-306546
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/31/2020
• Device Lot Number: 7081704
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 99