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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK 50ML CONCENTRIC LUER LOCK SYRINGE

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BECTON DICKINSON, S.A. BD PLASTIPAK 50ML CONCENTRIC LUER LOCK SYRINGE Back to Search Results
Catalog Number 300865
Device Problem Fungus in Device Environment (2316)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/12/2021
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. 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 the bd plastipak¿ 50ml concentric luer lock syringe experienced mold presence. The following information was provided by the initial reporter: contaminated syringe. Grey contaminant, appearing like mold inside top of syringe surface. Also transferred onto black plunger.
 
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Brand NameBD PLASTIPAK 50ML CONCENTRIC LUER LOCK SYRINGE
Type of DeviceSYRINGE
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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11285476
MDR Text Key230756292
Report Number3003152976-2021-00065
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeNZ
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number300865
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/27/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/24/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/11/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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