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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 Problems Defective Device (2588); Gas Leak (2946)
Patient Problems Regurgitation (2259); Discomfort (2330)
Event Date 06/08/2019
Event Type  Injury  
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 after injecting (b)(6) child with medication with a bd discardit¿ ii 20 ml syringe, the health professional noticed air bubbles and purged air in syringe and put on an electric syringe pump. Later child started to regurgitate and air was found in syringe. Syringe then changed. Child was uncomfortable and had to be scoped. The following information was provided by the initial reporter, translated from french to english: the syringe pump, the health professional noted air bubbles that he purged after it. An hour later, the child presented a regurgitation and there is air in the syringe (50% air and 50% liquid). The syringe was then changed. The tubing of the pump was checked, it was then not full of air but of the antibiotic product. The child however felt something uncomfortable for him, a break in the respiration. It was scoped. The child was examined which did not show any notable problems. There were no other abnormal events in the day. The syringe should be defective at the piston. Additional info: i put down the syringe containing an antibiotic, at the time of the insertion, i saw air bubbles rising while there was no air in the syringe or bubble. I purged that syringe and put it in the electric syringe pump. An hour later, it was half full of antibiotic and air while there was no liquid on the ground, so i thought this syringe was defective and it could be dangerous for a child. » the caregiver cannot say that the parent present did not touch the assembly. Has the device been used on a central line? no, peripheral lane. Was there any medical intervention due to the dysfunction? there was no medical intervention.
 
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Brand NameBD DISCARDIT¿ II 20 ML SYRINGE
Type of DeviceSYRINGE
Manufacturer (Section D)
BECTON DICKINSON, S.A.
cr mequinenza
s/n
fraga
Manufacturer (Section G)
BECTON DICKINSON, S.A.
cr mequinenza
s/n
fraga
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key8773614
MDR Text Key150529820
Report Number3002682307-2019-00395
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number300296
Device Lot Number1902289
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/14/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/20/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/09/2019 Patient Sequence Number: 1
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