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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD ULTRA FINE¿ MINI PEN NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE
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BECTON DICKINSON AND CO. BD ULTRA FINE¿ MINI PEN NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE Back to Search Results
Model Number 320119
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Blister (4537); Easy Bruising (4558)
Event Date 01/26/2023
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device expiration date: unknown.Device manufacture date: unknown.
 
Event Description
It was reported that after using the bd ultra fine¿ mini pen needle, the customer experienced an infection.The following information was provided by the initial reporter: stated, when he took injection with mini pen needles, "it stings and caused bruising and a painful smelly pus from my arm".
 
Manufacturer Narrative
H6: investigation summary no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.No dhr review can be carried out as lot number is unknown.
 
Event Description
It was reported that after using the bd ultra fine¿ mini pen needle, the customer experienced an infection.The following information was provided by the initial reporter: stated, when he took injection with mini pen needles, "it stings and caused bruising and a painful smelly pus from my arm".
 
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Brand Name
BD ULTRA FINE¿ MINI 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 Key16401002
MDR Text Key309869304
Report Number9616656-2023-00118
Device Sequence Number1
Product Code FMI
UDI-Device Identifier00382903201198
UDI-Public00382903201198
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/23/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number320119
Device Catalogue Number320119
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/26/2023
Initial Date FDA Received02/17/2023
Supplement Dates Manufacturer Received02/23/2023
Supplement Dates FDA Received03/13/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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