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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD SYRINGE

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BECTON DICKINSON, S.A. BD SYRINGE Back to Search Results
Catalog Number 301942
Device Problems Break (1069); Leak/Splash (1354)
Patient Problems Exposure to Body Fluids (1745); Needle Stick/Puncture (2462); Device Embedded In Tissue or Plaque (3165)
Event Date 01/16/2020
Event Type  Injury  
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that the bd¿ syringe needle pulled out of the hub during use and broke off in the patient's body. When removing the broken needle piece, the nurse was "stabbed" by it. This occurred on 2 separate occasions, but the dates and/or patient information are unknown. The following information was provided by the initial reporter, translated from (b)(6) to english: "during the process of blood drawing, the needle fell off from the needle hub and broke in the patient's body. At present, the needle had been taken out, and the medical staff was stabbed when pulling out the needle. " "when the nurse was removing the broken needle, nurse was injured by the needle. ".
 
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Brand NameBD SYRINGE
Type of DeviceSYRINGE
Manufacturer (Section D)
BECTON DICKINSON, S.A.
cr mequinenza
s/n
fraga
Manufacturer (Section G)
BECTON DICKINSON, S.A.
cr mequinenza
s/n
fraga
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key9671502
MDR Text Key188323628
Report Number3002682307-2020-00033
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/05/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number301942
Device Lot Number1811189
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/16/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/14/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/05/2020 Patient Sequence Number: 1
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