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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD NANO¿ ULTRA FINE¿ PEN NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE
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BECTON DICKINSON AND CO. BD NANO¿ ULTRA FINE¿ PEN NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE Back to Search Results
Model Number 320122
Device Problem Misconnection (1399)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/20/2022
Event Type  malfunction  
Event Description
It was reported that approximately 20 bd nano¿ ultra fine¿ pen needles were difficult to operate and attach to the syringe.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "have been having an issue with your bd nano ultra fine needles.Seems that there are approximately 20 needles in box of 100 that will not "puncture the syringe.If replaced, will usually work.".
 
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 approximately 20 bd nano¿ ultra fine¿ pen needles were difficult to operate and attach to the syringe.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "have been having an issue with your bd nano ultra fine needles.Seems that there are approximately 20 needles in box of 100 that will not "puncture the syringe.If replaced, will usually work.".
 
Manufacturer Narrative
Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A lot history review was carried out and no related non conformances were raised in association with this packaged lot concluding all inspections were performed as per the applicable operations and met qc specifications.H3 other text : see h10.
 
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Brand Name
BD NANO¿ ULTRA FINE¿ PEN NEEDLE
Type of Device
HYPODERMIC SINGLE LUMEN NEEDLE
Manufacturer (Section D)
BECTON DICKINSON AND CO.
pottery road
dun laoghaire co
Manufacturer (Section G)
BECTON DICKINSON AND CO.
pottery road
dun laoghaire co
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key15442707
MDR Text Key305715570
Report Number9616656-2022-00991
Device Sequence Number1
Product Code FMI
UDI-Device Identifier00382903201228
UDI-Public00382903201228
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K213478
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 09/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/16/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number320122
Device Catalogue Number320122
Device Lot Number1322180
Was Device Available for Evaluation? No
Date Manufacturer Received09/22/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/19/2022
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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