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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD MICROLANCE¿ NEEDLES

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BECTON DICKINSON, S.A. BD MICROLANCE¿ NEEDLES Back to Search Results
Catalog Number 304622
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Information (3190)
Event Date 12/11/2018
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. Medical device expiration date: unknown. (b)(6). Device manufacture date: unknown. 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 bd microlance¿ needle had a hair on a new hypodermic needle.
 
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Brand NameBD MICROLANCE¿ NEEDLES
Type of DeviceNEEDLE
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
8015652845
MDR Report Key8204449
MDR Text Key131775284
Report Number3002682307-2018-00336
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeFI
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 Pharmacist
Type of Report Initial,Followup,Followup
Report Date 01/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number304622
Device Lot NumberUNKNOWN
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 Received12/11/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 12/28/2018 Patient Sequence Number: 1
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