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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK¿ HYPODERMIC SYRINGE LUER LOK¿

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BECTON DICKINSON, S.A. BD PLASTIPAK¿ HYPODERMIC SYRINGE LUER LOK¿ Back to Search Results
Catalog Number 305959
Device Problems Device Markings/Labelling Problem (2911); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Information (3190)
Event Date 12/12/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(6). 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 plastipak¿ hypodermic syringe luer lok¿ had foreign matter and scale marking issue.
 
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Brand NameBD PLASTIPAK¿ HYPODERMIC SYRINGE LUER LOK¿
Type of DeviceSYRINGE
Manufacturer (Section D)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
Manufacturer (Section G)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key8204121
MDR Text Key131709699
Report Number3003152976-2018-00567
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 03/06/2019
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 Number305959
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 Received12/12/2018
Was Device Evaluated by Manufacturer? Yes
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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