MAUDE Adverse Event Report: BD BD 50 ML SYRINGE; SYRINGE, PISTON

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)

Patient Problem Injury (2348)

Event Date 02/14/2018

Event Type  malfunction  

Event Description

Pt blood glucose (bg) was in 50's, and pt would not take oral carbohydrates.Gave 12.5 grams iv push d5.D5 syringe broke at top with two plastic pieces and cut rn's hand.Another nurse came to bedside and noticed blood.Administering rn then noticed green attachment to patients iv was not attached either and patients iv was having backflow of blood.

• Brand Name: BD 50 ML SYRINGE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BD; one becton drive; franklin lakes NJ 07417
• MDR Report Key: 7365374
• MDR Text Key: 103311097
• Report Number: 7365374
• 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: 03/02/2018,03/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/02/2018
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/02/2018
• 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
• Patient Outcome(s): Other
• Patient Age: 30 YR