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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SYRINGE 1ML LS SP120
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BECTON DICKINSON, S.A. SYRINGE 1ML LS SP120 Back to Search Results
Catalog Number 303172
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/02/2021
Event Type  malfunction  
Manufacturer Narrative
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 syringe 1ml ls sp120 experienced leakage.The following information was provided by the initial reporter: the customer uses this product for covid-19 vaccination.According to the customer's report, the connection between the syringe hub and the needle was not good, resulting in leakage.
 
Event Description
It was reported that the syringe 1ml ls sp120 experienced leakage.The following information was provided by the initial reporter: the customer uses this product for covid-19 vaccination.According to the customer's report, the connection between the syringe hub and the needle was not good, resulting in leakage.
 
Manufacturer Narrative
Investigation summary : one syringe received for investigation.Upon visual inspection, no defect can be observed in the tip of the syringe.It is correctly molded with no burrs or defects.Ten retained from the same lot were evaluated, no defects or issues observed.A device history review was performed for lot 2011077, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device, including verification all critical dimensions are within specification and there is no damage on the product.Testing results were reviewed for the reported lot and found all product met required specifications.Based on the quality team's investigation, we are not able to identify a root cause related to our manufacturing process at this time.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.H3 other text : see h10.
 
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Brand Name
SYRINGE 1ML LS SP120
Type of Device
SYRINGE
Manufacturer (Section D)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
MDR Report Key12389471
MDR Text Key273153283
Report Number3003152976-2021-00524
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
NA
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 10/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number303172
Device Lot Number2011077
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/13/2021
Date Manufacturer Received10/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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