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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK TIP SYRINGE PISTON SYRINGE

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BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK TIP SYRINGE PISTON SYRINGE Back to Search Results
Model Number 309628
Device Problem Volume Accuracy Problem (1675)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/30/2021
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 the scale markings on the bd luer-lok¿ tip syringe were missing. The following information was provided by the initial reporter: "no 'ml' is marked on the syringe. Nothing is indicated at all. " "it was observed that the graduation marks on the syringe were missing. ".
 
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Brand NameBD LUER-LOK TIP SYRINGE
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 Key12380171
MDR Text Key269294143
Report Number1213809-2021-00601
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K941562
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 09/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number309628
Device Catalogue Number309628
Device Lot Number0002684
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/13/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/22/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/22/2020
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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