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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SYRINGE 30ML LL
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BECTON DICKINSON, S.A. SYRINGE 30ML LL Back to Search Results
Catalog Number 301229
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/22/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that syringe 30ml ll leaked.This occurred on 4 occasions.The following information was provided by the initial reporter: we have recently had several problems with syringes.We had 4 leaks from the syringe with a flow past the plunger, so we conclude that the stopper is not tight.
 
Manufacturer Narrative
H.6.Investigation: three samples and two photos were provided to our quality team for investigation.Through visual inspection of the product, a superficial black stain inside the syringe was observed which was identified to be ink from the marking process.The product was disassembled for further evaluation, there was no damage or molding defects noted in the plunger rod or other components that could have caused a leak and the stopper was verified to be properly assembled onto the plunger rod.A device history review was performed for the reported lot 2105003, no deviations or non-conformances were identified during the manufacturing process that could have contributed to the reported issues.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, including leakage testing.All returned samples underwent these tests and product was verified to meet required specifications, no leakages were observed.While we cannot identify a direct issue for either alleged defect at this time, the ink stain likely occurred during the marking process.
 
Event Description
It was reported that syringe 30ml ll leaked.This occurred on 4 occasions.The following information was provided by the initial reporter: we have recently had several problems with syringes.We had 4 leaks from the syringe with a flow past the plunger, so we conclude that the stopper is not tight.
 
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Brand Name
SYRINGE 30ML LL
Type of Device
SYRINGE
Manufacturer (Section D)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
MDR Report Key12200530
MDR Text Key264844072
Report Number3003152976-2021-00405
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 08/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number301229
Device Lot Number2105003
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/14/2021
Initial Date Manufacturer Received 06/22/2021
Initial Date FDA Received07/20/2021
Supplement Dates Manufacturer Received08/11/2021
Supplement Dates FDA Received08/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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