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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
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BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE LUER-LOK¿ TIP Back to Search Results
Catalog Number 301029
Device Problems Break (1069); Device Inoperable (1663)
Patient Problem No Patient Involvement (2645)
Event Date 06/01/2018
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.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7088988; medical device expiration date: 2022-03-31; device manufacture date: 2017-03-29.Medical device lot #: 7088992; medical device expiration date: 2022-04-30; device manufacture date: 2017-03-29.Medical device lot #: 7178880; medical device expiration date: 2022-06-30; device manufacture date: 2017-06-27.Medical device lot #: 7237636; medical device expiration date: 2022-07-31; device manufacture date: 2017-08-25.Medical device lot #: 7277752; medical device expiration date: 2022-09-30; device manufacture date: 2017-10-04.
 
Event Description
It was reported that before use a bd syringe luer-lok¿ tip was found with multiple malfunctions.Foreign matter, excess lubricant, volumetric issues, inclusions and damage.There was no report of exposure, injury or medical intervention needed.
 
Event Description
It was reported that before use a bd syringe luer-lok¿ tip was found with multiple malfunctions.Foreign matter, excess lubricant, volumetric issues, inclusions and damage.There was no report of exposure, injury or medical intervention needed.
 
Manufacturer Narrative
Investigation summary: 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 numbers 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 Name
BD SYRINGE LUER-LOK¿ TIP
Type of Device
SYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
MDR Report Key7621848
MDR Text Key112442294
Report Number1213809-2018-00377
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 foreign,other,user facility
Type of Report Initial,Followup
Report Date 09/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number301029
Device Lot NumberSEE H.10
Was Device Available for Evaluation? No
Date Manufacturer Received06/01/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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