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U.S. Department of Health and Human Services

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

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BECTON DICKINSON, S.A. BD SYRINGE WITH NEEDLE PISTON SYRINGE Back to Search Results
Catalog Number 301940
Device Problem Fungus in Device Environment (2316)
Patient Problem No Patient Involvement (2645)
Event Date 07/07/2020
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. (b)(4).
 
Event Description
It was reported that 3600 bd syringes with needle were found with "suspected mildew" on them before use, and black spots were seen on the outside of the packaging. The following information was provided by the initial reporter, translated from (b)(6) to english: "the equipment department found that when the large package was opened, suspected mildew was found on the appearance of part of the package. A total of 2 goods were admitted to hospital this time. Among them, most of the packages were glued to each other, and there were many black spots on the outside. ".
 
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Brand NameBD SYRINGE WITH NEEDLE
Type of DevicePISTON SYRINGE
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 Key10336353
MDR Text Key202217226
Report Number3002682307-2020-00231
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number301940
Device Lot Number1906102
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/07/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/27/2019
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: 07/28/2020 Patient Sequence Number: 1
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