MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD POSIFLUSH SURESCRUB; SYRINGE

Model Number 306559

Device Problems Device Displays Incorrect Message (2591); Device Sensing Problem (2917); Pressure Problem (3012)

Patient Problem No Information (3190)

Event Date 09/11/2017

Event Type  malfunction  

Event Description

Nurse reported the medfusion syringe pumps are having trouble recognizing the 10ml bd pre-filled flushes (the posiflush 10ml pre-filled normal saline flushes).The pump will read "invalid syringe size" and reseating the flush does not work.The workaround nursing has come up with is to use an alcohol wipe package or the label from a syringe and place it between the flange of the syringe and the slot the flange sits in on the right side of the pump.Then it will recognize the 10ml flush.Medical engineering evaluated and found the change in the plunger when posiflush came out caused increased drag and thereby increased pressure upon deployment of the fluid.After a matter of just a few minutes the pressure reading increases to the point that the pump shuts off.It reads this as an occlusion.Because of this we determined that a different flush has to be used to prevent the pressure increase.Per site reporter: bd does not recommend use of this syringe with pump.

• Brand Name: BD POSIFLUSH SURESCRUB
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 1 becton dr; franklin lakes NJ 07417
• MDR Report Key: 7027557
• MDR Text Key: 91915489
• Report Number: 7027557
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 306559
• Device Catalogue Number: 306559
• Device Lot Number: UNKNOWN
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/30/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: MEDFUSION SYRINGE PUMP