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

Model Number 309628

Device Problems Structural Problem (2506); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 03/25/2021

Event Type  malfunction  

Event Description

Upon drawing the medication into the syringe, the nurse noted a grey rubber piece in the syringe.We removed the plunger and took the piece out of the syringe.The piece does not fit through the syringe tip, so we believe this was left in the syringe during the manufacturing process.

• Brand Name: BD LUER-LOK
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11619072
• MDR Text Key: 243974499
• Report Number: 11619072
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 309628
• Device Catalogue Number: 309628
• Device Lot Number: 0314581
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/31/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 1460 DA