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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 Leak/Splash (1354)
Patient Problem Chemical Exposure (2570)
Event Date 03/05/2021
Event Type  Injury  
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 the bd plastipak¿ 50ml concentric luer lock syringe experienced leakage and led to chemotherapy drug exposure. It has not been specified whether medical intervention was administered as a result. The following information was provided by the initial reporter: as mentioned by telephone, we have again noticed a leak in the plunger of a 50ml syringe ref 300865 (batch 2010099). This time the syringe has been kept and can be sent to you for expertise. However, the incident occurred during the preparation of an expensive cytotoxic product. Due to the defect in the syringe, the chemotherapy had to be re-prepared. The incident resulted in leakage of cytotoxic product and thus exposure of the personnel in the chemotherapy preparation unit. In one of these cases.
 
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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 Key11593710
MDR Text Key243701720
Report Number3003152976-2021-00178
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 05/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2021
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? Device Returned to Manufacturer
Date Returned to Manufacturer03/29/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/05/2021
Was Device Evaluated by Manufacturer? Yes
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: 03/30/2021 Patient Sequence Number: 1
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