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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE; PISTON SYRINGE
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BECTON DICKINSON, S.A. BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE; PISTON SYRINGE Back to Search Results
Catalog Number 300865
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/29/2021
Event Type  malfunction  
Manufacturer Narrative
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 bd plastipak¿ 50ml concentric luer lock syringe leaked.The following information was provided by the initial reporter: "it was reported that the seal around the plunger appears to not be intact, which was discovered when the syringe was installed in a syringe driver pump for medication infusion.The medication then began to leak out behind the plunger and on to the floor.".
 
Event Description
It was reported that bd plastipak¿ 50ml concentric luer lock syringe leaked.The following information was provided by the initial reporter: "it was reported that the seal around the plunger appears to not be intact, which was discovered when the syringe was installed in a syringe driver pump for medication infusion.The medication then began to leak out behind the plunger and on to the floor.".
 
Manufacturer Narrative
H.6.Investigation: one syringe and photo received for investigation, upon visual inspection of the sample, leakage can be confirmed as liquid was detected past the stopper.The stopper is correctly assembled.When barrel is examined, it can be seen there is external damage between 30 and 40 marks of the scale.Additionally, functional test was performed on syringe and no leakage observed.Possible root cause is associated with hit during assembly process in the silicone station.A device history review was performed for lot 2012062 no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.
 
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Brand Name
BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
Manufacturer (Section G)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12708304
MDR Text Key278761483
Report Number3003152976-2021-00710
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number300865
Device Lot Number2012062
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/13/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/23/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/30/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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