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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SYRINGE S2 20ML 21GA 1-1/2IN
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BECTON DICKINSON, S.A. SYRINGE S2 20ML 21GA 1-1/2IN Back to Search Results
Catalog Number 300330
Device Problem Leak/Splash (1354)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/29/2021
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.(b)(4).
 
Event Description
It was reported that syringe s2 20ml 21ga 1-1/2in plunger came out of the syringe.The following information was provided by the initial reporter: plunger came out of the syringe barrel and this caused drug spillage.
 
Manufacturer Narrative
H6: investigation summary a device history record review was completed for provided lot number 2009504.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defects and all quality tests were found to be within specification.As samples were unavailable for return, twenty retained samples of the same lot number were obtained from the manufacturing facility.The retained samples were evaluated and no signs of defect were observed.The material used to manufacture the discardit syringe has been selected and tested to resist normal conditions of use.The retaining ring force is tested for each lot released.In this case, all tested were found to be within specification.At this time, an exact cause related to the manufacturing process could not be determined of this incident.H3 other text : see h10.
 
Event Description
It was reported that syringe s2 20ml 21ga 1-1/2in plunger came out of the syringe.The following information was provided by the initial reporter: plunger came out of the syringe barrel and this caused drug spillage.
 
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Brand Name
SYRINGE S2 20ML 21GA 1-1/2IN
Type of Device
SYRINGE
Manufacturer (Section D)
BECTON DICKINSON, S.A.
cr mequinenza
s/n
fraga, huesca 22520
SP  22520
MDR Report Key11381744
MDR Text Key234049102
Report Number3002682307-2021-00075
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 05/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number300330
Device Lot Number2009504
Was Device Available for Evaluation? No
Date Manufacturer Received05/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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