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U.S. Department of Health and Human Services

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

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BD / BECTON DICKINSON BD 50ML SYRINGE LUER-LOK TIP SYRINGE, PISTON Back to Search Results
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).
 
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Brand NameBD 50ML SYRINGE LUER-LOK TIP
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
BD / BECTON DICKINSON
laagstraat
BE
MDR Report Key12121413
MDR Text Key260258980
Report NumberMW5102292
Device Sequence Number1
Product Code FMF
Reporter Country CodeUS
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received07/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberREF 309653
Device Lot Number1112977
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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