MAUDE Adverse Event Report: WINTHROP SANOFI-AVENTIS LOVENOX SYRINGE; PRE-LOADED SYRINGE

Lot Number CN948

Device Problem Unintended Ejection (1234)

Patient Problem Needle Stick/Puncture (2462)

Event Date 04/06/2021

Event Type  malfunction  

Event Description

When the safety was engaged after medication administration, the needle shot out of the syringe and stuck the patient in the arm.

• Brand Name: LOVENOX SYRINGE
• Type of Device: PRE-LOADED SYRINGE
• Manufacturer (Section D): WINTHROP SANOFI-AVENTIS; 55 corporate drive; bridgewater NJ 08807
• MDR Report Key: 11684990
• MDR Text Key: 246016168
• Report Number: 11684990
• 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: 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: CN948
• 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: 04/07/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 8030 DA