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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD 60 ML BD SYRINGE WITH BD LUER-LOK
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BD 60 ML BD SYRINGE WITH BD LUER-LOK Back to Search Results
Catalog Number 309653
Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Patient Problem No Code Available (3191)
Event Date 06/09/2014
Event Type  Injury  
Event Description
During an abdominal procedure, anesthesia was using the 60ml syringe in the sampling port on the anesthesia circuit to give albuterol inhalant.When syringe was removed from the port on the anesthesia circuit, it was noted that the tip was not on the syringe resulting in an additional procedure for patient (bronchoscopy).The tip was found in the anesthesia circuit closer to where it attaches to the machine and not the patient.
 
Manufacturer Narrative
The sample has been received for analysis.Upon completion of the investigation a supplemental report will be submitted.(b)(4).
 
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Brand Name
60 ML BD SYRINGE WITH BD LUER-LOK
Type of Device
60 ML BD SYRINGE
Manufacturer (Section D)
BD
one becton dr.
franklin lakes NJ 07417
Manufacturer Contact
diane parker
one becton dr.
franklin lakes, NJ 07417
8015652534
MDR Report Key3963995
MDR Text Key16185337
Report Number2243072-2014-00144
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 07/09/2014
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? No
Device Operator Health Professional
Device Expiration Date03/31/2019
Device Catalogue Number309653
Device Lot Number4098442
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer06/24/2014
Initial Date Manufacturer Received 06/09/2014
Initial Date FDA Received07/09/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2014
Is the Device Single Use? Yes
Patient Sequence Number1
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