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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD DISCARDIT¿ II SYRINGE WITH DETACHED BD MICROLANCE¿ NEEDLE; PISTON SYRINGE
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BECTON DICKINSON, S.A. BD DISCARDIT¿ II SYRINGE WITH DETACHED BD MICROLANCE¿ NEEDLE; PISTON SYRINGE Back to Search Results
Catalog Number 301001
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/06/2023
Event Type  malfunction  
Manufacturer Narrative
Initial reporter addr 1: (b)(6).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 while using bd discardit¿ ii syringe with detached bd microlance¿ needle leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: complained that drug is leaking from the sides of the plunger.
 
Manufacturer Narrative
H6: investigation summary a device history record review was completed for provided material number 301001 and batch number 2210507.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.As samples were unavailable for return, twenty (20) retained samples were obtained for evaluation from the manufacturing facility.The retained samples were examined; however, no signs of defect were identified h3 other text : see h10.
 
Event Description
It was reported while using bd discardit¿ ii syringe with detached bd microlance¿ needle leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: complained that drug is leaking from the sides of the plunger.
 
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Brand Name
BD DISCARDIT¿ II SYRINGE WITH DETACHED BD MICROLANCE¿ NEEDLE
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON, S.A.
cr mequinenza
s/n
fraga, huesca 22520
SP  22520
Manufacturer (Section G)
BECTON DICKINSON, S.A.
cr mequinenza
s/n
fraga, huesca 22520
SP   22520
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8448235433
MDR Report Key16613526
MDR Text Key312121970
Report Number2243072-2023-00473
Device Sequence Number1
Product Code FMF
UDI-Device Identifier00382903010011
UDI-Public(01)00382903010011
Combination Product (y/n)N
Reporter Country CodeIN
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 05/15/2023
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 Number301001
Device Lot Number2210507
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/06/2023
Initial Date FDA Received03/24/2023
Supplement Dates Manufacturer Received05/15/2023
Supplement Dates FDA Received05/30/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/03/2022
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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