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U.S. Department of Health and Human Services

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

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BECTON DICKINSON, S.A. BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE HYPODERMIC SYRINGE Back to Search Results
Catalog Number 300865
Device Problems Break (1069); Detachment Of Device Component (1104); Entrapment of Device (1212)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/26/2018
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. 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 before use a bd plastipak¿ luer-lock syringe was found broken as¿ the top of the plunger had broken off and became lodged in the barrel. There was no report of exposure, injury or medical intervention needed.
 
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Brand NameBD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE
Type of DeviceHYPODERMIC SYRINGE
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 Key7314852
MDR Text Key101713339
Report Number3003152976-2018-00096
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
Type of Report Initial,Followup
Report Date 03/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number300865
Device Lot Number1709242
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/28/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/26/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/11/2017
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: 03/05/2018 Patient Sequence Number: 1
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