MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD LUER-LOK; SYRINGE, PISTON

Model Number 309657

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 09/08/2020

Event Type  malfunction  

Event Description

Opened bd 3ml syringe to administer medication and syringe had no markings for measurement.

• Brand Name: BD LUER-LOK
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 10612642
• MDR Text Key: 209391443
• Report Number: 10612642
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903096572
• UDI-Public: (01)00382903096572
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 309657
• Device Catalogue Number: 309657
• Device Lot Number: 0183088
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/09/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1