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

Lot Number 9294412

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 10/07/2020

Event Type  malfunction  

Event Description

Several bd 10ml syringes with luer-lok tips as well as several bd 20ml syringes with luer-lok tips were found to be leaking around the stopper of the plunger when filled with compounded sterile product.All of these had to be discarded.

• Brand Name: BD 10ML SYRINGE LUER-LOK TIP
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY
• MDR Report Key: 10683952
• MDR Text Key: 211749791
• Report Number: MW5097235
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• 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: 10/09/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 9294412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1