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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD DISCARDIT¿ II; PISTON SYRINGE
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BECTON DICKINSON, S.A. BD DISCARDIT¿ II; PISTON SYRINGE Back to Search Results
Catalog Number 300296
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/04/2022
Event Type  malfunction  
Event Description
It was reported that the bd discardit¿ syringe experienced leakage.The following information was provided by the initial reporter: hospital pharmacists have had an leakage issue with 20 ml discardit syringes for a long time.
 
Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: medical device lot #: 2204187.Medical device expiration date: 31-mar-2022.Device manufacture date: 02-apr-2022.Medical device lot #: 2205129.Medical device expiration date: 30-apr-2027.Device manufacture date: 04-may-2022.
 
Event Description
It was reported that the bd discardit¿ syringe experienced leakage.The following information was provided by the initial reporter: hospital pharmacists have had an leakage issue with 20 ml discardit syringes for a long time.
 
Manufacturer Narrative
H6: investigation summary: a device history record review was completed for provided material number 300296 and lot number 2205129.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 this incident, twenty retained samples were obtained for evaluation by our quality engineer team; however, the retained samples did not display any signs of leakage.
 
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Brand Name
BD DISCARDIT¿ II
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
8015296192
MDR Report Key15317418
MDR Text Key300450311
Report Number3002682307-2022-00223
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeFI
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 09/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/29/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number300296
Device Lot NumberSEE H10
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/20/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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