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U.S. Department of Health and Human Services

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

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BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ TIP DISPOSABLE SYRINGE; PISTON SYRINGE Back to Search Results
Model Number 309657
Device Problem Partial Blockage (1065)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/30/2021
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
 
Event Description
It was reported that the bd luer-lok¿ tip disposable syringe needle became blocked at the.5ml mark and the plunger was difficult to move.This occurred 2 separate times during use.The following information was provided by the initial reporter: "when infusing medication in 3ml syringe via medfusion syringe pump, pump rings occludded at 0.5 ml volume remaining.?plunger stiff.When pulled back to fill syringe issue appears to have resolved.This is the first reported incident, however the note left by the staff reported states it has been happening for a few weeks.The syringe was prepared and delivered with the medication ready to administer by pharmacy and thus lot number is unknown.".
 
Event Description
It was reported that the bd luer-lok¿ tip disposable syringe needle became blocked at the.5ml mark and the plunger was difficult to move.This occurred 2 separate times during use.The following information was provided by the initial reporter: "when infusing medication in 3ml syringe via medfusion syringe pump, pump rings occludded at 0.5 ml volume remaining.?plunger stiff.When pulled back to fill syringe issue appears to have resolved.This is the first reported incident, however the note left by the staff reported states it has been happening for a few weeks.The syringe was prepared and delivered with the medication ready to administer by pharmacy and thus lot number is unknown.".
 
Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
 
Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 12/22/2021.H.6.Investigation: one photo and one loose 3ml syringe (p/n 309657) were received.The sample was visually evaluated and tested for both functionality and volumetric accuracy.No visible defects were observed on the syringe and the sample yielded acceptable results for volumetric accuracy, along with being able to properly expel the fluid.The sample was acceptable per product specification requirements.No claims can be made about the syringe pump as it is not a bd product.Since the sample received did not display the reported defect a potential root cause could not be defined and corrective actions are not necessary.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.H3 other text : see h.10.
 
Event Description
It was reported that the bd luer-lok¿ tip disposable syringe needle became blocked at the.5ml mark and the plunger was difficult to move.This occurred 2 separate times during use.The following information was provided by the initial reporter: "when infusing medication in 3ml syringe via medfusion syringe pump, pump rings occludded at 0.5 ml volume remainging.Plunger stiff.When pulled back to fill syringe issue appears to have resolved.This is the first reported incident, however the note left by the staff reported states it has been happening for a few weeks.The syringe was prepared and delivered with the medication ready to administer by pharmacy and thus lot number is unknown.".
 
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Brand Name
BD LUER-LOK¿ TIP DISPOSABLE SYRINGE
Type of Device
PISTON 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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key13003581
MDR Text Key285405212
Report Number1213809-2021-00813
Device Sequence Number1
Product Code FMF
UDI-Device Identifier30382903096573
UDI-Public30382903096573
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 Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
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 NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/22/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/16/2021
Initial Date FDA Received12/14/2021
Supplement Dates Manufacturer Received01/05/2022
Supplement Dates FDA Received01/13/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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