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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 Known Impact Or Consequence To Patient (2692)
Event Date 11/26/2019
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 prior to use medication is leaking between the grooves of the stopper and does not penetrate the piston with a bd plastipak¿ 50ml concentric luer lock syringe.The following information was provided by the initial reporter: the cytotoxic liquid enters in between the black grooves in the rubber stopper.The liquid stays between the black grooves and does not penetrate into the piston.They have no pictures of the 2 syringes.
 
Manufacturer Narrative
H.6.Investigation: twenty samples were received for evaluation by our quality engineer.The product was visually inspected, no leakage was observed.The product was disassembled for further inspection, there was no damage noted in the plunger rod or other components that could have caused a leak.A device history review was performed for the reported lot 1908230, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Ten additional retained samples of lot 1908230 were used to conduct a leakage test.The product was visually inspected, no defects or damage was noted, and no leak was identified.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.Based on the available information we are not able to determine a root cause at this time.H3 other text : see h.10.
 
Event Description
It was reported that prior to use medication is leaking between the grooves of the stopper and does not penetrate the piston with a bd plastipak¿ 50ml concentric luer lock syringe.The following information was provided by the initial reporter: the cytotoxic liquid enters in between the black grooves in the rubber stopper.The liquid stays between the black grooves and does not penetrate into the piston.They have no pictures of the 2 syringes.
 
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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
MDR Report Key9510836
MDR Text Key204438709
Report Number3003152976-2019-00869
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
N/A
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 02/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number300865
Device Lot Number1908230
Date Manufacturer Received12/06/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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