MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BD 20ML SYRINGE WITH LUER-LOK TIP; PISTON, SYRINGE

Catalog Number REF 305617

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

An 80 bd 20ml syringes with luer-lok tip was found to be leaking from tip of the plunger after being filled with compounded sterile product.These 80 syringes had to be wasted.Fda safety report id# (b)(4).

• Brand Name: BD 20ML SYRINGE WITH LUER-LOK TIP
• Type of Device: PISTON, SYRINGE
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY; franklin lakes NJ 07417
• MDR Report Key: 10507201
• MDR Text Key: 206326506
• Report Number: MW5096468
• Device Sequence Number: 1
• Product Code: FMF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: REF 305617
• Device Lot Number: 9184756
• 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