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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 20ML E/T; SYRINGE, PISTON
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BECTON DICKINSON SYRINGE 20ML E/T; SYRINGE, PISTON Back to Search Results
Catalog Number 300613
Device Problem Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/11/2024
Event Type  malfunction  
Event Description
Seal on the plunger has a piece of rubber on it.Additional information from customer: the piece of rubber is attached to the stopper.
 
Manufacturer Narrative
Pr (b)(4): initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.H3 other text : see h10 manufacture narrative.
 
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Brand Name
SYRINGE 20ML E/T
Type of Device
SYRINGE, PISTON
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
Manufacturer Contact
helen cox (mdr)
75 north fairway drive
vernon hills, IL 60061
8473935694
MDR Report Key18958394
MDR Text Key338767888
Report Number3003152976-2024-00182
Device Sequence Number1
Product Code FMF
UDI-Device Identifier30382903006138
UDI-Public(01)30382903006138
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K110771
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/13/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number300613
Device Lot Number2312046
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/11/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/12/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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