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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD ULTRA-FINE¿ NANO PEN NEEDLE 4MM (5/32¿) X 32G; HYPODERMIC SINGLE LUMEN NEEDLE
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BECTON DICKINSON AND CO. BD ULTRA-FINE¿ NANO PEN NEEDLE 4MM (5/32¿) X 32G; HYPODERMIC SINGLE LUMEN NEEDLE Back to Search Results
Catalog Number 320883
Device Problem Misconnection (1399)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/16/2022
Event Type  malfunction  
Event Description
It was reported while using bd ultra-fine¿ nano pen needle 4mm (5/32¿) x 32g the shield would not attach.There was no report of patient impact.The following information was provided by the initial reporter: consumer reported that she has difficulty re-shielding with the inner cover after injection.Consumer also reported patient end needle slightly bent before injection.
 
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.
 
Manufacturer Narrative
H6: investigation summary: no samples 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.
 
Event Description
It was reported while using bd ultra-fine¿ nano pen needle 4mm (5/32¿) x 32g the shield would not attach.There was no report of patient impact.The following information was provided by the initial reporter: consumer reported that she has difficulty re-shielding with the inner cover after injection.Consumer also reported patient end needle slightly bent before injection.
 
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Brand Name
BD ULTRA-FINE¿ NANO PEN NEEDLE 4MM (5/32¿) X 32G
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 Key15557170
MDR Text Key306499462
Report Number9616656-2022-01094
Device Sequence Number1
Product Code FMI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133532
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 10/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/06/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number320883
Device Lot Number1351576
Was Device Available for Evaluation? No
Date Manufacturer Received10/20/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/17/2021
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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