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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SYRINGE 50ML LL; PISTON SYRINGE
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BECTON DICKINSON, S.A. SYRINGE 50ML LL; PISTON SYRINGE Back to Search Results
Catalog Number 300865
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
Initial reporter phone#: (b)(6).Initial reporter zip: (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 syringe 50ml ll had leakage issues.The following information was provided by the initial reporter: "the plunger does not appear to form an adequate seal which causes liquid to leak into the inside of the syringe beneath the plunger and then out of the bottom.".
 
Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 8/25/2021.H.6.Investigation: samples received for investigation, upon visual inspection no molding or other defects observed on the syringe.Barrel does not present any damage that could have deformed their shape.The stopper is correctly assembled, when the syringe is disassembled the plunger do not show any defect.Further testing was conducted, no sign of leakage occurred.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.Dhr from lot 2105021 was reviewed not finding any annotation or deviation regarding the alleged defect.Based on the quality team's investigation, we are not able to identify a root cause related to our manufacturing process at this time.H3 other text : see h.10.
 
Event Description
It was reported syringe 50ml ll had leakage issues.The following information was provided by the initial reporter: "the plunger does not appear to form an adequate seal which causes liquid to leak into the inside of the syringe beneath the plunger and then out of the bottom.".
 
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Brand Name
SYRINGE 50ML LL
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
MDR Report Key12411568
MDR Text Key271233173
Report Number3003152976-2021-00538
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 10/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number300865
Device Lot Number2105021
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/25/2021
Date Manufacturer Received10/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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