MAUDE Adverse Event Report: BECTON DICKINSON BD 30 ML SYRINGE

Catalog Number 302832

Device Problems Contamination (1120); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Information (3190)

Event Date 04/24/2018

Event Type  Injury  

Event Description

Pharmacy staff noted what appears to be grease or dirt on several 30 ml syringes.Syringes were in packaging and sealed.

• Brand Name: BD 30 ML SYRINGE
• Type of Device: BD 30 ML SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; franklin lakes NJ 07417
• MDR Report Key: 7472465
• MDR Text Key: 107069074
• Report Number: MW5076879
• 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: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 302832
• Device Lot Number: 8004943
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention