MAUDE Adverse Event Report: BECTON DICKINSON AND CO., BECTON DICKINSON BD 10 ML LUER-LOK SYRINGE; SYRINGE, PISTON

Model Number 309664

Device Problem Corroded (1131)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/28/2018

Event Type  malfunction  

Event Description

Crna prepping for procedure.Noted that syringe appeared to have rust-colored material/contamination between threads of syringe and in the barrel of the syringe.

• Brand Name: BECTON DICKINSON BD 10 ML LUER-LOK SYRINGE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BECTON DICKINSON AND CO., ; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8206332
• MDR Text Key: 132045670
• Report Number: MW5082688
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: 309664
• Device Catalogue Number: REF 309644
• Device Lot Number: 8238836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2018
• 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