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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD DISCARDIT II SYRINGE
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BECTON DICKINSON, S.A. BD DISCARDIT II SYRINGE Back to Search Results
Catalog Number 309050
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/09/2019
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 has been reported that the bd discardit¿ ii syringe has been found experiencing leakage during use.The following has been provided by the initial reporter: they claim that our syringes do not seal properly.They are using these syringes on the hematology for taking blood samples and samples of bone marrow.There is leakage of blood.Our syringes are bad quality and the haematooncology ward does not use them any more.No proper vacuum for taking samples during trepanobiopsy.
 
Manufacturer Narrative
H.6 investigation summary: bd has been provided with a sample for catalog 309050 lot 1906165 to investigate for this record.Visual examination of the sample under magnification shows a leakage through the plunger rod.As a result, bd was able to verify the reported issue.This issue could be produced during the handling of the product through the manufacturing process or in the plunger assembly machine.The device history review showed no indication of the alleged defect.Considering our in-coming and in-process inspection and since this is the first time this lot is reported for this defect, no corrective actions are required at this time.H3 other text : see h.10.
 
Event Description
It has been reported that the bd discardit¿ ii syringe has been found experiencing leakage during use.The following has been provided by the initial reporter: they claim that our syringes do not seal properly.They are using these syringes on the hematology for taking blood samples and samples of bone marrow.There is leakage of blood.Our syringes are bad quality and the haematooncology ward does not use them any more.No proper vacuum for taking samples during trepanobiopsy.
 
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Brand Name
BD DISCARDIT II SYRINGE
Type of Device
SYRINGE
Manufacturer (Section D)
BECTON DICKINSON, S.A.
cr mequinenza
s/n
fraga
MDR Report Key9521626
MDR Text Key190605546
Report Number3002682307-2019-00689
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 02/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/31/2024
Device Catalogue Number309050
Device Lot Number1906165
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/09/2019
Initial Date FDA Received12/26/2019
Supplement Dates Manufacturer Received12/09/2019
Supplement Dates FDA Received02/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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