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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON BD DISCARDIT¿ II SYRINGE; PISTON SYRINGE
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BECTON DICKINSON BD DISCARDIT¿ II SYRINGE; PISTON SYRINGE Back to Search Results
Catalog Number 300844
Device Problems Partial Blockage (1065); Material Separation (1562); Air/Gas in Device (4062)
Patient Problem Discomfort (2330)
Event Date 07/24/2023
Event Type  malfunction  
Event Description
It was reported that the bd discardit¿ ii syringe had issues with air bubbles entering it while reconstituting the medication, as well as the needle being blocked and pulling out of the hub during the injection.The following information was provided by the initial reporter: "while using the discardit, staffs find difficulty to aspirate the blood and medications, finding bubbles in the syringe and needle coming out of the syringe while reconstituting the medication.Also difficult to give im injections with discardit.The syringe is getting stuck while injecting medication.
 
Manufacturer Narrative
The manufacturing location for this product is bawal, india.This site is not registered with the fda.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H.3.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 syringe had issues with air bubbles entering it while reconstituting the medication, as well as the needle being blocked and pulling out of the hub during the injection.The following information was provided by the initial reporter: "while using the discardit, staffs find difficulty to aspirate the blood and medications, finding bubbles in the syringe and needle coming out of the syringe while reconstituting the medication.Also difficult to give im injections with discardit.The syringe is getting stuck while injecting medication.
 
Manufacturer Narrative
H6: investigation summary no sample (including photos) was received for evaluation of discardit ii 2ml with 24x1 from lot number 3055269 regarding material number 300844 with the reported issue of aspirate / draw (cannot / difficult), bubbles / voids in molded part, needle pulled out of hub, plunger movement difficult.The device history review was completed for material number 300844 with lot number 3055269 and there was no quality notification found from its production date to end of dispatch date.The investigation and simulation were carried out on retention samples where the investigating team has use one sample for plunger movement difficult & results found with in limit.The investigating team has visually checked the samples for bubbles / voids in molded part, needle pulled out of hub and no defect was found in the retention samples.The exact root cause can only be determined if we receive the original sample.See h10.
 
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Brand Name
BD DISCARDIT¿ II SYRINGE
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer Contact
jennifer suh
9450 south state street
sandy, UT 84070
8448235433
MDR Report Key17485137
MDR Text Key320879230
Report Number2243072-2023-01399
Device Sequence Number1
Product Code FMF
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 08/09/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/08/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number300844
Device Lot Number3055269
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/09/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/24/2023
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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