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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD PLASTIC NON-STERILE LUER-LOK¿ TIP SYRINGE

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BECTON DICKINSON MEDICAL SYSTEMS BD PLASTIC NON-STERILE LUER-LOK¿ TIP SYRINGE Back to Search Results
Catalog Number 301027
Device Problems Particulates (1451); Failure to Align (2522); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/01/2018
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. (b)(6). 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 with the use of the bd plastic non-sterile luer-lok¿ tip syringe there was an issue with multiple defects. It was stated with the devices ¿there was particle/contamination, damaged devices, inclusion, a mis-aligned gasket, and a print issue. ¿ there was no report of injury or further medical intervention.
 
Event Description
It was reported with the use of the bd plastic non-sterile luer-lok tip syringe there was an issue with multiple defects. It was stated with the devices ¿there was particle/contamination, damaged devices, inclusion, a mis-aligned gasket, and a print issue. ¿ there was no report of injury or further medical intervention.
 
Manufacturer Narrative
Since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident, therefore a root cause could not be determined. 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. 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 NameBD PLASTIC NON-STERILE LUER-LOK¿ TIP SYRINGE
Type of DeviceSYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
MDR Report Key7589355
MDR Text Key110957974
Report Number1213809-2018-00368
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K980987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other
Type of Report Initial,Followup
Report Date 08/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date08/31/2022
Device Catalogue Number301027
Device Lot Number7239853
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/01/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 06/11/2018 Patient Sequence Number: 1
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