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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE; PISTON SYRINGE
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BECTON DICKINSON, S.A. BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE; PISTON SYRINGE Back to Search Results
Catalog Number 300865
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/23/2023
Event Type  malfunction  
Event Description
It was reported that the bd plastipak¿ concentric luer lock syringe plunger was deformed.2 of 3.The following information was provided by the initial reporter, translated from french to english: the black stopper at the plunger was deformed.
 
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 bd plastipak¿ concentric luer lock syringe plunger was deformed.2 of 3.The following information was provided by the initial reporter, translated from french to english: the black stopper at the plunger was deformed.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 24-jul-2023.H6: investigation summary: one 50ml syringe sample and photo received by our quality team for investigation.Through visual evaluation, it was observed that the stopper was incorrectly assembled to the plunger, distorted against the barrel wall, which can lead to leakage past stopper and air bubbles.A device history was performed and found no no-conformances related to the reported issue during production of batch 2212067.This issue was determined to have occurred as a result of improper alignment of the plunger/stopper to the barrel during assembly.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.
 
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Brand Name
BD PLASTIPAK¿ 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
phillip emmert
9450 south state street
sandy, UT 84070
8448235433
MDR Report Key16799250
MDR Text Key313860020
Report Number3003152976-2023-00148
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeFR
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 08/09/2023
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 Number300865
Device Lot Number2212067
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/31/2023
Initial Date FDA Received04/24/2023
Supplement Dates Manufacturer Received08/09/2023
Supplement Dates FDA Received08/22/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/05/2022
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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