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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SYRINGE S2 2ML 25GA 1IN BD CHINA PISTON SYRINGE

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BECTON DICKINSON, S.A. SYRINGE S2 2ML 25GA 1IN BD CHINA PISTON SYRINGE Back to Search Results
Catalog Number 301941
Device Problem Fungus in Device Environment (2316)
Patient Problem No Patient Involvement (2645)
Event Date 10/09/2020
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: unknown. Device manufacture date: unknown. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. (b)(4). Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured. A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured. (b)(4).
 
Event Description
It was reported that an unspecified bd syringe contained foreign matter. The following information was provided by the initial reporter: "at 8 o'clock in the morning on (b)(6) 2020, the emergency department found that the syringe had visible contaminants and mildew stains in the unopened state while preparing conventional consumables. Immediately report to the device department, and replace qualified products for standby. Did not cause harm to the patient. ".
 
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Brand NameSYRINGE S2 2ML 25GA 1IN BD CHINA
Type of DevicePISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON, S.A.
cr mequinenza
s/n
fraga, huesca NJ 22520
SP 22520
Manufacturer (Section G)
BECTON DICKINSON, S.A.
cr mequinenza
s/n
fraga, huesca NJ 22520
SP 22520
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key10775398
MDR Text Key214616573
Report Number2243072-2020-01773
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeJA
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 01/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number301941
Device Lot Number1901191
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 Received01/11/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/08/2019
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: 11/02/2020 Patient Sequence Number: 1
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