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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU BD MICRO-FINE¿ + PEN NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE
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BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU BD MICRO-FINE¿ + PEN NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE Back to Search Results
Catalog Number 329489
Device Problem Complete Blockage (1094)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/18/2022
Event Type  malfunction  
Manufacturer Narrative
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 micro-fine¿ + pen needle was blocked during use.The following information was provided by the initial reporter, translated from chinese: "during use, it is found that the needle is blocked and cannot be used normally".
 
Event Description
It was reported that the bd micro-fine¿ + pen needle was blocked during use.The following information was provided by the initial reporter, translated from chinese: "during use, it is found that the needle is blocked and cannot be used normally".
 
Manufacturer Narrative
H6: investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Dhr was reviewed and there were not any qns or other events that could be related to this complaint.Clog test was conducted on 7pcs retention samples and all no needle clog fail found.Base on investigation above, the certain cause cannot be concluded at the moment.
 
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Brand Name
BD MICRO-FINE¿ + PEN NEEDLE
Type of Device
HYPODERMIC SINGLE LUMEN NEEDLE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
no.1 liangpu street
suzhou industrial park
suzhou 21512 6
CH  215126
Manufacturer (Section G)
BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
no.1 liangpu street
suzhou industrial park
suzhou 21512 6
CH   215126
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key16078350
MDR Text Key308446265
Report Number3014704491-2022-00714
Device Sequence Number1
Product Code FMI
Combination Product (y/n)N
Reporter Country CodeCH
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 01/20/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number329489
Device Lot Number9185329
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/20/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/30/2019
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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