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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT); HYPODERMIC SINGLE LUMEN NEEDLE
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BECTON DICKINSON AND CO. BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT); HYPODERMIC SINGLE LUMEN NEEDLE Back to Search Results
Model Number 320550
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/10/2022
Event Type  malfunction  
Manufacturer Narrative
Medical device lot #: 2008377 was reported, however, this is not a lot # manufactured for the reported catalog #.Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported while using bd nano¿ 2nd gen pen needles 32g x 4mm (100 count) there were attachment issues.There was no report of patient impact.The following information was provided by the initial reporter: consumer stated, when she tried to use a pen needle last night it would not attach to novolog pen.".
 
Event Description
It was reported while using bd nano¿ 2nd gen pen needles 32g x 4mm (100 count) there were attachment issues.There was no report of patient impact.The following information was provided by the initial reporter: consumer stated, when she tried to use a pen needle last night, it would not attach to novolog pen.
 
Manufacturer Narrative
H6: investigation summary no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Due to the batch being unknown, no dhr review can be completed.
 
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Brand Name
BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT)
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 Key15724118
MDR Text Key306923353
Report Number9616656-2022-01191
Device Sequence Number1
Product Code FMI
UDI-Device Identifier00382903205509
UDI-Public00382903205509
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K182320
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 11/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number320550
Device Catalogue Number320550
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/11/2022
Initial Date FDA Received11/04/2022
Supplement Dates Manufacturer Received11/15/2022
Supplement Dates FDA Received12/02/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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