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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 Problem Loose or Intermittent Connection (1371)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/30/2022
Event Type  malfunction  
Event Description
It was reported that 15 bd nano¿ 2nd gen pen needles were difficult to attach to their pen.The following information was provided by the initial reporter: "consumer reported he's having issues attaching non patient end to pen stated, they will not stay on 15 pen needles affected".
 
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter e-mail: unknown.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 15 bd nano¿ 2nd gen pen needles were difficult to attach to their pen.The following information was provided by the initial reporter: "consumer reported he's having issues attaching non patient end to pen stated, they will not stay on 15 pen needles affected".
 
Manufacturer Narrative
H6: investigation summary customer returned a total of 23 used 4mm, 32 gauge nano pro pen needles.No teardrop labels were returned for lot identification.The pen needles were visually inspected.22 of the pen needles were found to have bent needles on the non-patient side of the hub¿s needle cannula.This damage shows the user having difficulty attaching the pen needle, as the bent cannula would disrupt normal usage.Based on the damage present, the needles bending may have occurred accidentally while the user was preparing the pen needle for use, potentially if the pen was not properly aligned with the cannula.The remaining sample could be attached to a test pen without issue.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 samples received, embecta found that 22 of the pen needles had become bent on the non-patient side.This damage could interfere with the pen needle attaching to the insulin pen.The root cause of the needles bending appears to be accidental damage from stresses caused by the user during routine use.This would result in being unable to attach the insulin pen as intended.
 
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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 Key15670737
MDR Text Key306798771
Report Number9616656-2022-01143
Device Sequence Number1
Product Code FMI
UDI-Device Identifier00382903205509
UDI-Public(01)00382903205509
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 11/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/25/2022
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 Number1314125
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/08/2022
Date Manufacturer Received01/04/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/10/2021
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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