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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 Insufficient Information (4580)
Event Date 08/24/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Investigation summary: the issue described in the complaint appears to pertain to what is known as dead space. Dead space does not affect volumetric accuracy of the syringe. This product is manufactured and sold in accordance with international organization for standardization (iso) 7886-1. The amount of dead space allowed for this product size is 0. 07ml. The reported quantity of 0. 04ml is well within the accepted dead space volume per product specification. Since no samples displaying the reported condition were received the alleged defect could not be confirmed and corrective actions are not necessary. 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.
 
Event Description
It was reported when using the bd luer-lok¿ tip syringe there was an issue with the syringe - volumetric accuracy. The following information was provided by the initial reporter. The customer stated: "after administration of medication the nurse noticed that 0. 04 ml remained in the syringe. It was only after she had placed the injection and pushed the plunger down, that she noticed the syringe was not empty.
 
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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 Key12502897
MDR Text Key273152016
Report Number1213809-2021-00644
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 foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/07/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number309628
Device Catalogue Number309628
Device Lot Number0321677
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 Received08/24/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/16/2020
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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