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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD NANO¿ PRO ULTRA-FINE¿ PEN NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE
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BECTON DICKINSON AND CO. BD NANO¿ PRO ULTRA-FINE¿ PEN NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE Back to Search Results
Catalog Number 320555
Device Problem Misconnection (1399)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/10/2022
Event Type  malfunction  
Event Description
It was reported that the bd nano¿ pro ultra-fine¿ pen needle was hard to attach.The following information was provided by the initial reporter: consumer reported pen needles are hard to attach to her pen stated, she cannot use the new pen needles because of the poor design stated, she really struggles to attach pen needle to pen.
 
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
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.
 
Event Description
It was reported that the bd nano¿ pro ultra-fine¿ pen needle was hard to attach.The following information was provided by the initial reporter: consumer reported pen needles are hard to attach to her pen stated, she cannot use the new pen needles because of the poor design stated, she really struggles to attach pen needle to pen.
 
Event Description
It was reported that the bd nano¿ pro ultra-fine¿ pen needle was hard to attach.The following information was provided by the initial reporter: consumer reported pen needles are hard to attach to her pen, stated, she cannot use the new pen needles because of the poor design, stated, she really struggles to attach pen needle to pen.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 05-jan-2023.H6: investigation summary: the customer returned two unused pen needles 0.2mm x 4mm 32g (lot#1342185) and a single use disposable pen injector.Consumer reported that the pen needles are hard to attach.The returned pen needles were visually inspected, and no damages were observed.The tear drop label was removed during the investigation and both the pen needles were tested with a pen injector, and both the needles were attached and detached as intended.Also, the needles were tested for flow, and saline expelled through the needle as intended.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.Based on the sample received, embecta was not able to confirm the customer¿s indicated failure of pen needle do not attach as intended.Root cause cannot be determined at this time as the issue is unconfirmed.H3 other text : see h10.
 
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Brand Name
BD NANO¿ PRO 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 Key15928785
MDR Text Key308045869
Report Number9616656-2022-01319
Device Sequence Number1
Product Code FMI
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Consumer
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 02/02/2023
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 Lay User/Patient
Device Catalogue Number320555
Device Lot Number1342185
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/10/2022
Initial Date FDA Received12/06/2022
Supplement Dates Manufacturer Received12/19/2022
02/02/2023
Supplement Dates FDA Received01/05/2023
02/17/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/08/2021
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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