MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BECTON DICKINSON SALINE FLUSH; SALINE, VASCULAR ACCESS FLUSH

Model Number 8110

Device Problem Compatibility Problem (2960)

Patient Problem Insufficient Information (4580)

Event Date 02/22/2021

Event Type  malfunction  

Event Description

Bd alaris is stating and verified that the only the bd alaris 306499 saline flush syringe 10 ml with 10 ml.Saline is approved for use with their bd alaris model 8110 syringe pump module.A bd #306504 saline flush syringe in a 5 ml.Size was previously available and discontinued by bd.Having only a 10ml.Syringe with 10 ml.Of saline is problematic to hospitals with nicu's.A 10ml.Saline flush volume is not safe for use with pre-term neonatal infants where specific medication administration protocols specify carefully measured saline flushes.Best practice is to have a 10ml.Syringe with 3ml.Of saline for neonate use.This minimizes the risk to a neonatal patient in the event that an accidental bolus of saline is administered.Bd does not offer a 3ml.Volume in any saline flush syringes currently compatible with the bd alaris model 8110 syringe pump module.Pushing our 7ml of excess saline is not an option, as that increases the risk of infection.Lastly, bd's requirement to utilize the #306499 saline flush syringe exclusively substantially increases the cost of the saline flush syringes over identical bd syringes such as the #306546.Fda safety report id# (b)(4).

• Brand Name: BECTON DICKINSON SALINE FLUSH
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY
• MDR Report Key: 11505860
• MDR Text Key: 240791845
• Report Number: MW5100028
• Device Sequence Number: 1
• Product Code: NGT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8110
• Device Catalogue Number: 306499
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other