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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE LUER-LOK TIP WITH BD PRECISIONGLIDE NEEDLE; PISTON SYRINGE
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BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE LUER-LOK TIP WITH BD PRECISIONGLIDE NEEDLE; PISTON SYRINGE Back to Search Results
Model Number 309581
Device Problem Leak/Splash (1354)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 03/05/2020
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 bd precisionglide¿ needle separated from the bd syringe luer-lok¿ tip during the injection and remained in the patient's injection site.The following information was provided by the initial reporter: "consumer reported the needle with hub assembly came off when injecting and stayed in his site.Consumer reported this same syringe when drawing up solution was getting air bubbles.".
 
Event Description
It was reported that the bd precisionglide¿ needle separated from the bd syringe luer-lok¿ tip during the injection and remained in the patient's injection site.The following information was provided by the initial reporter: "consumer reported the needle with hub assembly came off when injecting and stayed in his site.Consumer reported this same syringe when drawing up solution was getting air bubbles.".
 
Manufacturer Narrative
H.6.Investigation summary: no photos or samples were received for evaluation.As a result, the reported condition were received a potential root cause could not be defined.No corrective actions are required at this time.A device history review was conducted for lot number 9207416.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.
 
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Brand Name
BD SYRINGE LUER-LOK TIP WITH BD PRECISIONGLIDE NEEDLE
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
MDR Report Key9879336
MDR Text Key198957933
Report Number1213809-2020-00208
Device Sequence Number1
Product Code FMF
UDI-Device Identifier30382903095811
UDI-Public30382903095811
Combination Product (y/n)N
PMA/PMN Number
K980987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup
Report Date 03/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number309581
Device Catalogue Number309581
Device Lot Number9207416
Was Device Available for Evaluation? No
Date Manufacturer Received03/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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