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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 Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/06/2022
Event Type  malfunction  
Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field.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) the pen needle was difficult to apply properly.There was no report of patient impact.The following information was provided by the initial reporter: finding when placing the pen needle onto wife's pen, it does not want to thread on properly.
 
Event Description
It was reported while using bd nano¿ 2nd gen pen needles 32g x 4mm (100 count) the pen needle was difficult to apply properly.There was no report of patient impact.The following information was provided by the initial reporter: finding when placing the pen needle onto wifes pen, it does not want to thread on properly.
 
Manufacturer Narrative
H6: 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.
 
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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 Key16040878
MDR Text Key308349297
Report Number9616656-2022-01409
Device Sequence Number1
Product Code FMI
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 Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 01/10/2023
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 Other
Device Model Number320550
Device Catalogue Number320550
Device Lot Number2074819
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/06/2022
Initial Date FDA Received12/23/2022
Supplement Dates Manufacturer Received01/10/2023
Supplement Dates FDA Received01/27/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/15/2022
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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