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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 3ML LL 200 S/C PISTON SYRINGE

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BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 3ML LL 200 S/C PISTON SYRINGE Back to Search Results
Model Number 309657
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/27/2021
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident. No root cause can be determined as no samples were received. Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect. Examination of the product involved may provide clarification as to the cause for the reported failure. Complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored monthly. Our business team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported syringe 3ml ll 200 s/c was unable to contain medication. The following information was provided by the initial reporter: "the syringe used for. Diluent had a crack in it and the solution seeped out when the nurse injected the vial. ".
 
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Brand NameSYRINGE 3ML LL 200 S/C
Type of DevicePISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
Manufacturer (Section G)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12546054
MDR Text Key273767383
Report Number1213809-2021-00676
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K110771
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
Report Date 09/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number309657
Device Catalogue Number309657
Device Lot Number0079124
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 Received08/31/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/19/2020
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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