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

Model Number 303310

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/22/2021

Event Type  No Answer Provided  

Event Description

A machine piece was found in the sealed package.Syringe appears unaffected.Manufacturer response for 20ml syringe, 20ml syringe (per site reporter): notified bd representative and requested and rga & mailer.They mailed an investigation closure letter last month.Attached to this report, they acknowledged and confirmed the defect and explained their corrective action plan.

• Brand Name: BD
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 12318176
• MDR Text Key: 266406958
• Report Number: 12318176
• 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: Nurse
• Type of Report: Initial
• Report Date: 08/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 303310
• Device Catalogue Number: 303310
• Device Lot Number: 0318887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/02/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/13/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1