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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
Catalog Number 320550
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/14/2023
Event Type  malfunction  
Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.E.1.The customer's address is unknown.(b)(6), usa has been used as a default.H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that the bd nano¿ 2nd gen pen needle cap was loose and would not attach.The following information was provided by the initial reporter: "when i refilled my prescription, my pharmacy, refilled using your pen needles.I have safety concerns about the manufacturing of these needles, at least the box i received.The outer cap is not secure.Very often, i have had the outer cap fall off.When i am done dispensing my medication and recap the needle, i am prone to getting stuck with the needle after capping the pen/needle with the outer clear plastic cap due to it falling off.I have tried to be extra careful to press the cap on harder and multiple times to try to prevent the cap from coming off while i remove the needle from the pen so i can dispose of it.This is concerning as i don't want to get my finger stuck/pricked with the needle.This is from bd nano 2nd gen 4mm pen needles lot no 2180165 exp 2027-07-31.I am unsure if it is just this box/lot or your needle design.I did not have this issue with the other manufacturer's needles that i had been using for several years.The needles from the other manufacture had a secure 'click' type feel to them when recapping and i never once had a cap come off by mistake.".
 
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¿ 2nd gen pen needle cap was loose and would not attach.The following information was provided by the initial reporter: "when i refilled my prescription, my pharmacy, refilled using your pen needles.I have safety concerns about the manufacturing of these needles, at least the box i received.The outer cap is not secure.Very often, i have had the outer cap fall off.When i am done dispensing my medication and recap the needle, i am prone to getting stuck with the needle after capping the pen/needle with the outer clear plastic cap due to it falling off.I have tried to be extra careful to press the cap on harder and multiple times to try to prevent the cap from coming off while i remove the needle from the pen so i can dispose of it.This is concerning as i don't want to get my finger stuck/pricked with the needle.This is from bd nano 2nd gen 4mm pen needles lot no 2180165 exp 2027-07-31.I am unsure if it is just this box/lot or your needle design.I did not have this issue with the other manufacturer's needles that i had been using for several years.The needles from the other manufacture had a secure 'click' type feel to them when recapping and i never once had a cap come off by mistake.".
 
Event Description
It was reported that the bd nano¿ 2nd gen pen needle cap was loose and would not attach.The following information was provided by the initial reporter: "when i refilled my prescription, my pharmacy, refilled using your pen needles.I have safety concerns about the manufacturing of these needles, at least the box i received.The outer cap is not secure.Very often, i have had the outer cap fall off.When i am done dispensing my medication and recap the needle, i am prone to getting stuck with the needle after capping the pen/needle with the outer clear plastic cap due to it falling off.I have tried to be extra careful to press the cap on harder and multiple times to try to prevent the cap from coming off while i remove the needle from the pen so i can dispose of it.This is concerning as i don't want to get my finger stuck/pricked with the needle.This is from bd nano 2nd gen 4mm pen needles lot no 2180165 exp 2027-07-31.I am unsure if it is just this box/lot or your needle design.I did not have this issue with the other manufacturer's needles that i had been using for several years.The needles from the other manufacture had a secure 'click' type feel to them when recapping and i never once had a cap come off by mistake.".
 
Manufacturer Narrative
The following fields have been updated due to additional information: d.9.Device available for eval?: yes d.9.Returned to manufacturer on: 06nov2023.H.6.Investigation summary: samples were received and an investigation was performed.This is the 1st complaint for the reported lot number.A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot.Embecta was not able to duplicate or confirm the indicated issue and based on trend analysis no further action is required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Based on the above, no additional investigation and corrective/preventative action (capa) or situational analysis (sa) is required.
 
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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
jennifer suh
9450 south state street
sandy, UT 84070
8448235433
MDR Report Key17653845
MDR Text Key322383140
Report Number9616656-2023-00940
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 Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 11/16/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number320550
Device Lot Number2180165
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received11/16/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/29/2022
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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