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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD SYRINGE 20ML LL 120/PKG; PISTON SYRINGE
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BECTON DICKINSON, S.A. BD SYRINGE 20ML LL 120/PKG; PISTON SYRINGE Back to Search Results
Catalog Number 300629
Device Problems Volume Accuracy Problem (1675); Missing Information (4053)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/26/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used as a default.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 syringe 20ml ll 120/pkg had scale marking missing.The following information was provided by the initial reporter: "we would like to inform you that we have found 20 ml luer lock syringes (ref (b)(4)) without graduation ".
 
Event Description
It was reported that bd syringe 20ml ll 120/pkg had scale marking missing.The following information was provided by the initial reporter: "we would like to inform you that we have found 20 ml luer lock syringes (ref (b)(4)) without graduation".
 
Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for evaluation?: yes.D9: returned to manufacturer on: 11/29/2021.H6: investigation: two samples and photos received for investigation, upon visual inspection of the samples received it can be seen no scale has been printed in the barrel of the syringes.A device history review was performed and found no non-conformances associated with this issue during the production of lot 2102013, all product was manufactured according to specification.Possible root cause, due to a failure in the trigger that guides the barrel to be correctly positioned in the moment of scale transference in the marking machine.This failure caused a misalignment causing scale resulted compressed and not printed.
 
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Brand Name
BD SYRINGE 20ML LL 120/PKG
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 Key12861483
MDR Text Key281152009
Report Number3003152976-2021-00774
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeBE
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 12/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number300629
Device Lot Number2102013
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/29/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/17/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2021
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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