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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 NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE
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BECTON DICKINSON AND CO. BD NANO¿ 2ND GEN PEN NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE Back to Search Results
Model Number 320550
Device Problems Leak/Splash (1354); Misconnection (1399)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/25/2022
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
 
Event Description
It was reported that the bd nano¿ 2nd gen pen needle experienced leakage and was difficult to operate.The following information was provided by the initial reporter: consumer reported he finds nano 2nd gen pen needle difficult to use.The redesign is causing him to lose insulin.
 
Manufacturer Narrative
H.6.Investigation: 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.
 
Event Description
It was reported that the bd nano¿ 2nd gen pen needle experienced leakage and was difficult to operate.The following information was provided by the initial reporter: consumer reported he finds nano 2nd gen pen needle difficult to use.The redesign is causing him to lose insulin.
 
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Brand Name
BD NANO¿ 2ND GEN 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 Key14407286
MDR Text Key291717627
Report Number9616656-2022-00554
Device Sequence Number1
Product Code FMI
UDI-Device Identifier00382903205509
UDI-Public00382903205509
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K212015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/16/2022
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
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/17/2022
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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