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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD DISCARDIT¿ II SYRINGE; PISTON SYRINGE
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BECTON DICKINSON, S.A. BD DISCARDIT¿ II SYRINGE; PISTON SYRINGE Back to Search Results
Catalog Number 309110
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/02/2023
Event Type  malfunction  
Event Description
It was reported that the bd discardit¿ ii syringe plunger leaked.The following information was provided by the initial reporter, translated from portuguese to english: the syringe towards the collection tube there are several drips on the floor.".
 
Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H3.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 plunger leaked.The following information was provided by the initial reporter, translated from portuguese to english: the syringe towards the collection tube there are several drips on the floor.".
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 31-may-2023.H6: investigation summary: a device history record review was completed for provided material number 309110 and lot number 2210152.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.To aid in the investigation of this issue, four (4) sample units were returned for evaluation.However, through inspection of the samples, no signs of defect were observed.The provided samples did not display any functionality issue.The medication used or a special method of handling (high temperatures, pressures, several uses, etc.) could affect the functionality of the syringe.At this time, an exact cause could not be identified.
 
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Brand Name
BD DISCARDIT¿ II SYRINGE
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
5859 farinon drive
san antonio, TX 78249
8448235433
MDR Report Key17001011
MDR Text Key315910751
Report Number3002682307-2023-00139
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodePO
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 08/14/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/25/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number309110
Device Lot Number2210152
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/14/2023
Was Device Evaluated by Manufacturer? Yes
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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