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

Device Problem Retraction Problem (1536)

Patient Problem Needle Stick/Puncture (2462)

Event Date 11/13/2019

Event Type  malfunction  

Event Description

During administration of lovenox medication, nurse sustained a needle stick injury because the needle did not retract properly as designed.Specific identifying numbers of this device not available.Device was discarded at the time of use.

• Brand Name: BECTON AND DICKINSON
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY INC; one becton drive; franklin lakes NJ 07417
• MDR Report Key: 9473036
• MDR Text Key: 170899130
• Report Number: 9473036
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/03/2019
• Date Report to Manufacturer: 12/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other