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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD 20 ML SYRINGE WITH NEEDLE

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BECTON DICKINSON, S.A. BD 20 ML SYRINGE WITH NEEDLE Back to Search Results
Catalog Number 301948
Device Problem Fungus in Device Environment (2316)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/27/2019
Event Type  malfunction  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that bd¿ 20 ml syringe with needle had mold on it. This was discovered before use. The following information was provided by the initial reporter: when unpacking, mildew was found on the push rod of a 20ml syringe, the outer package was intact, and the validity period was all within the validity period. Has been sealed. At present, no similar problems have been found in the same batch of products in other hospitals, and samples of problems have been sent to the headquarters for further investigation.
 
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Brand NameBD 20 ML SYRINGE WITH NEEDLE
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 Key9586986
MDR Text Key190692117
Report Number3002682307-2020-00002
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
N/A
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 02/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number301948
Device Lot Number1811222
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 Received12/26/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/12/2018
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: 01/14/2020 Patient Sequence Number: 1
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