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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON BD UNDISCLOSED DISPOSABLE SYRINGE; SYRINGE, PISTON
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BECTON DICKINSON BD UNDISCLOSED DISPOSABLE SYRINGE; SYRINGE, PISTON Back to Search Results
Catalog Number UNKNOWN
Device Problem Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/11/2024
Event Type  malfunction  
Manufacturer Narrative
H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.B3.The date received by manufacturer has been used for this field.E1.Address information was not provided, therefore, xx was used as a place holder.
 
Event Description
It was reported that bd undisclosed disposable syringe stopper is loose the following information was provided by the initial reporter, translated from portuguese to english: i've always worked with bd disposable syringes, but the last 2 batches have come with the rubber on the cap loose, making it very difficult to collect blood.
 
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Brand Name
BD UNDISCLOSED DISPOSABLE SYRINGE
Type of Device
SYRINGE, PISTON
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
helen cox (mdr)
75 north fairway drive
vernon hills, IL 60061
8473935694
MDR Report Key19008147
MDR Text Key339134104
Report Number2243072-2024-00478
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
UNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/15/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/11/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Type of Device Usage Initial
Patient Sequence Number1
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