MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY B D LUER-LOK TIP 60ML SYRINGE

Lot Number 5202594

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Information (3190)

Event Date 10/23/2015

Event Type  Injury  

Event Description

Foreign material sealed in syringe package 60ml bd syringe.Diagnosis or reason for use: used in iv compounding.

• Brand Name: B D LUER-LOK TIP 60ML SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY; franklin lakes NJ 07417
• MDR Report Key: 5187472
• MDR Text Key: 29924599
• Report Number: MW5057513
• 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: 10/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/20/2020
• Device Lot Number: 5202594
• Other Device ID Number: 00382903096534
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/23/2015
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention