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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD SYRINGE 20ML E/T PRECISE PISTON SYRINGE

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BECTON DICKINSON MEDICAL (SINGAPORE) BD SYRINGE 20ML E/T PRECISE PISTON SYRINGE Back to Search Results
Catalog Number 300142
Device Problem Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/06/2021
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: unknown. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. Device manufacture date: unknown.
 
Event Description
It was reported when using the bd syringe 20ml e/t precise, the device experienced leakage. This event occurred ten times. The following information was provided by the initial reporter. The customer stated: are faulty leaking at the base of the syringe. As the rubber doesn't fit correctly. Please inform the company / supplier. Have removed a whole box of the shelf 10 were ¿ tried all the same.
 
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Brand NameBD SYRINGE 20ML E/T PRECISE
Type of DevicePISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
Manufacturer (Section G)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12425431
MDR Text Key271337609
Report Number8041187-2021-00800
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
NA
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 09/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number300142
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/19/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/13/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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