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U.S. Department of Health and Human Services

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

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BECTON DICKINSON, S.A. BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE Back to Search Results
Catalog Number 300865
Device Problem Leak/Splash (1354)
Patient Problem Chemical Exposure (2570)
Event Date 03/02/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. 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 chemotherapy medicine leaked from 4 separate bd plastipak¿ concentric luer lock syringes during use. In one case, a member of personnel was exposed to the cytotoxic medication. The following information was provided by the initial reporter, translated from french to english: "we have encountered 4 times a leakage problem on the 50ml syringes ref 300865 (batch 2010099). During sampling, a loss of piston resistance is felt. When injecting, a liquid outlet occurs at the piston. The devices concerned that have been in contact with cytotoxic products have not been kept. " "the incident resulted in leakage of cytotoxic product and thus exposure of the personnel in the chemotherapy preparation unit. In one of these cases, the leak resulted in the need to restart the preparation with the use of a new vial of medicine at a cost of 3076¿. ".
 
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Brand NameBD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE
Type of DevicePISTON SYRINGE
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 Key11573138
MDR Text Key266014876
Report Number3003152976-2021-00169
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeFR
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 04/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number300865
Device Lot Number2010099
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 Received04/16/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/26/2020
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: 03/25/2021 Patient Sequence Number: 1
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