MAUDE Adverse Event Report: BD 0.9% SODIUM CHLORIDE 10ML FLUSH - POSIFLUSH ; SALINE, VASCULAR ACCESS FLUSH

Lot Number 8362826

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Rn unwrapped a saline flush, expelled a couple of mls, then noticed a foreign object in the syringe.We sequestered the syringe, left 2 messages on bd product line.Rn says never hooked up to iv port or any manipulation by him except to expel a couple of mls.Have not heard back from mfr to see if they want to see the product.

• Brand Name: 0.9% SODIUM CHLORIDE 10ML FLUSH - POSIFLUSH
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BD
• MDR Report Key: 8597131
• MDR Text Key: 144693169
• Report Number: MW5086513
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065463
• UDI-Public: 0130382903065463
• 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: 05/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/31/2021
• Device Lot Number: 8362826
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1