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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD DISCARDIT¿ II 20 ML SYRINGE
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BECTON DICKINSON, S.A. BD DISCARDIT¿ II 20 ML SYRINGE Back to Search Results
Catalog Number 300296
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/07/2021
Event Type  malfunction  
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 discardit¿ ii 20 ml syringe experienced foreign matter in the fluid path.The following information was provided by the initial reporter: dispensing, white flocs are found in the syringe.
 
Manufacturer Narrative
Investigation summary: no photos or samples were received by our quality team for evaluation.The team has evaluated twenty retained samples of the reported lot and no defect was observed.No white flocs or foreign matter was found.The team was not able to confirm the reported issue.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.Based on customer feedback, the team has concluded that the white flocs could be composed of plastic shavings coming from the own syringe and accumulated during the barrel transport process.The exact root cause is not able to be determined.
 
Event Description
It was reported that the bd discardit¿ ii 20 ml syringe experienced foreign matter in the fluid path.The following information was provided by the initial reporter: dispensing, white flocs are found in the syringe.
 
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Brand Name
BD DISCARDIT¿ II 20 ML SYRINGE
Type of Device
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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12625419
MDR Text Key276945764
Report Number3002682307-2021-00552
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeCH
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 11/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number300296
Device Lot Number2004168
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/06/2020
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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