MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY; SYRINGE, PISTON

Device Problem Fluid/Blood Leak (1250)

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

Event Date 03/01/2020

Event Type  malfunction  

Event Description

Report being submitted for tracking purposes as we do not have model, lot or serial numbers available.Nyicu (nursery intensive care unit) rn reported that new 3ml (bd) dopamine syringe that was started by day shift late in shift was found (by day shift rn while reporting off) to be leaking.The underside of the infusion pump was wet.New syringe was scanned and the dopamine transferred to a 5ml syringe (as this was 2nd 3ml dopamine syringe found to leak on this date).Had to transfer back to a 3ml syringe later in night when dosage decreased to under.1ml/hr.Syringe/buff cap saved in bag and given to manager.

Event Description

Report being submitted for tracking purposes as we do not have model, lot or serial numbers available.Nyicu (nursery intensive care unit) rn reported that new 3ml (bd) dopamine syringe that was started by day shift late in shift was found (by day shift rn while reporting off) to be leaking.The underside of the infusion pump was wet.New syringe was scanned and the dopamine transferred to a 5ml syringe (as this was 2nd 3ml dopamine syringe found to leak on this date).Had to transfer back to a 3ml syringe later in night when dosage decreased to under.1ml/hr.Syringe/buff cap saved in bag and given to manager.

• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY; one becton drive; franklin lakes NJ 07417
• MDR Report Key: 9943935
• MDR Text Key: 187081882
• Report Number: 9943935
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/24/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/09/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/09/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1