MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD SAFETYGLIDE 1 ML SYRINGE; SYRINGE, PISTON

Model Number 305945

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

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

Event Date 01/11/2018

Event Type  malfunction  

Event Description

Nurse attempted to raise white lever to cover needle (safety mechanism) and the entire needle assembly flew off the syringe and landed on the floor without the needle being covered.

• Brand Name: BD SAFETYGLIDE 1 ML SYRINGE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 1 becton drive; franlkin lakes NJ 07417 6800
• MDR Report Key: 7288862
• MDR Text Key: 100681132
• Report Number: 7288862
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/12/2018,02/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 305945
• Device Catalogue Number: 305945
• Other Device ID Number: 0100382903059454
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/12/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 01/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NOT KNOWN.
• Patient Age: 54 YR