MAUDE Adverse Event Report: BECTON DICKINSON SAFETYGLIDE; SYRINGE

Catalog Number 305930

Device Problems Bent (1059); Device Slipped (1584); Activation, Positioning or Separation Problem (2906)

Patient Problem Laceration(s) (1946)

Event Date 07/08/2014

Event Type  malfunction  

Event Description

Rn was giving a shot to the patient.Upon depressing the plunger, the plunger bent, the needle skipped out of the patient scraping her, scratched through the glove of the rn.Upon inspection a scrape to the rn's finger was hard to discern, no blood was drawn, but could be visible after multiple cleanings with alcohol pads.Hiv and acute hep panel ordered.Employee states syringe not saved and disposed of in 3w sharps container in med room.This event occurred while administering a heparin injection.

• Brand Name: SAFETYGLIDE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; one becton drive; franklin lakes NJ 07417
• MDR Report Key: 4212578
• MDR Text Key: 5041693
• Report Number: 4212578
• Device Sequence Number: 1
• Product Code: MEG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 10/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 305930
• Device Lot Number: 8360272
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/17/2014
• Event Location: Hospital
• Date Report to Manufacturer: 10/30/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1