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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER LOCK SYRINGE PISTON SYRINGE

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BECTON DICKINSON MEDICAL SYSTEMS BD LUER LOCK SYRINGE PISTON SYRINGE Back to Search Results
Model Number 309628
Device Problems Break (1069); Leak/Splash (1354)
Patient Problem Insufficient Information (4580)
Event Date 10/20/2021
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: unknown. Device manufacture date: unknown. 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. The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed. Examination of the product involved may provide clarification as to the cause for the reported failure. 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 when using the bd luer lock syringe, the device experienced needle and syringe separation and leakage. The following information was provided by the initial reporter. The customer stated: it was reported to the tga by a confidential customer that i was administering the vaccination to the patient on his left deltoid. As i was administering the vaccine, the needle and the syringe detached from each other and some of the dose spilled into the floor and into my eyes.
 
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Brand NameBD LUER LOCK 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 Key12832917
MDR Text Key280948139
Report Number1213809-2021-00774
Device Sequence Number1
Product Code FMF
UDI-Device Identifier30382903096283
UDI-Public30382903096283
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K941562
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number309628
Device Catalogue Number309628
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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