MAUDE Adverse Event Report: BD / BECTON DICKINSON BD 50ML SYRINGE LUER-LOK TIP; SYRINGE, PISTON

Model Number REF 309653

Device Problem Contamination (1120)

Patient Problem Insufficient Information (4580)

Event Date 06/29/2021

Event Type  malfunction  

Event Description

A pharmacy technician took an unopened bd 50ml syringe leur-lok syringe into our iv room.She opened the package in the iv hood and withdrew 50ml of dextrose from an iv bag.She noticed what appears to be an inch-long human hair within the syringe attached to the base of the plunger.The technician was fully gowned, gloved, and had her hair up in a hair net.She discarded the preparation and escalated to pharmacy management for fear of a contaminated syringe.Fda safety report id# (b)(4).

• Brand Name: BD 50ML SYRINGE LUER-LOK TIP
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BD / BECTON DICKINSON ; laagstraat; BE
• MDR Report Key: 12121413
• MDR Text Key: 260258980
• Report Number: MW5102292
• 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: 06/30/2021

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: Health Professional
• Device Model Number: REF 309653
• Device Lot Number: 1112977
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/02/2021
• 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