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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD SYRINGE S2¿ 5ML

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BECTON DICKINSON, S.A. BD SYRINGE S2¿ 5ML Back to Search Results
Catalog Number 309050
Device Problems Leak/Splash (1354); Gas Leak (2946)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/09/2019
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. (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 the plunger had a defect with a bd syringe s2¿ 5ml. The following information was provided by the initial reporter, translated from (b)(6) to english: defect of the plunger, air bubble formation from the bottom of the syringe and leakage of the contents. Problem occurred on 3 syringes of the same batch.
 
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Brand NameBD SYRINGE S2¿ 5ML
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 Key8546276
MDR Text Key144451277
Report Number3002682307-2019-00268
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeFR
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
Report Date 05/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number309050
Device Lot Number1812174
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 Received04/09/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/03/2018
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: 04/24/2019 Patient Sequence Number: 1
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