MAUDE Adverse Event Report: BECTON DICKINSON & CO. BD 50 ML SYRINGE, LUER-LOK TIP SYRINGE, PISTON

Lot Number 0170292

Device Problem Fluid Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/23/2020

Event Type  malfunction  

Event Description

Bd 60 cc syringes leak medicine around the plunger. Allows medicine to leak/loss of meds. Possible inaccurate dosing. Fda safety report id# (b)(4).

• Brand Name: BD 50 ML SYRINGE, LUER-LOK TIP
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BECTON DICKINSON & CO.
• MDR Report Key: 10747716
• MDR Text Key: 213672238
• Report Number: MW5097485
• Device Sequence Number: 1
• Product Code: FMF
• 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: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Lot Number: 0170292
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 10/27/2020 Patient Sequence Number: 1