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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD ULTRA FINE¿ PEN NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE
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BECTON DICKINSON AND CO. BD ULTRA FINE¿ PEN NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE Back to Search Results
Model Number 320109
Device Problem Misconnection (1399)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/30/2022
Event Type  malfunction  
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 the bd ultra fine¿ pen needle hub was smaller than normal and difficult to attach to the pen.The following information was provided by the initial reporter: "consumer reported that the needle hub is smaller than usual and she is having difficulty holding it while trying to attach it to the pen.She stated that it falls on the floor before she can attach it.".
 
Manufacturer Narrative
H6: investigation summary no samples (including photos) from lot# 1307320 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 ultra fine¿ pen needle hub was smaller than normal and difficult to attach to the pen.The following information was provided by the initial reporter: "consumer reported that the needle hub is smaller than usual and she is having difficulty holding it while trying to attach it to the pen.She stated that it falls on the floor before she can attach it.".
 
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Brand Name
BD 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 Key15506863
MDR Text Key306254934
Report Number9616656-2022-01062
Device Sequence Number1
Product Code FMI
UDI-Device Identifier00382903201099
UDI-Public(01)00382903201099
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K213478
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 11/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/29/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number320109
Device Catalogue Number320109
Device Lot Number1307320
Was Device Available for Evaluation? No
Date Manufacturer Received11/23/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/03/2021
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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