MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD ULTRA-FINE¿ NANO PEN NEEDLE 4MM (5/32¿) X 32G; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	8975
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2023
Type of Reportable Event	Malfunction
Additional 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.Device expiration date: unknown.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd ultra-fine¿ nano pen needle 4mm (5/32¿) x 32g cannula broke off.The following information was provided by the initial reporter: consumer reported injected into thigh and found flexpen would not move or press out insulin during injecting.Found needle broke off at sometime.
Additional Manufacturer Narrative
H6: investigation summary no samples including photos were returned therefore the complaint could not be confirmed and the root cause is undetermined.Due to the batch being unknown, no dhr review can be completed.H3 other text : see h10.
Event or Problem Description
It was reported that the bd ultra-fine¿ nano pen needle 4mm (5/32¿) x 32g cannula broke off.The following information was provided by the initial reporter: consumer reported injected into thigh and found flexpen would not move or press out insulin during injecting found needle broke off at sometime.

• Brand Name: BD ULTRA-FINE¿ NANO PEN NEEDLE 4MM (5/32¿) X 32G
• Common Device Name: 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 ; 8448235433
• MDR Report Key: 16519349
• Report Number: 9616656-2023-00193
• Device Sequence Number: 17756986
• Product Code: FMI
• UDI-Device Identifier: 10885403897511
• UDI-Public: (01)10885403897511
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K213478
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2023

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
• Operator of Device: Lay User/Patient
• Device Model Number: 8975
• Device Catalogue Number: 320883
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2023
• Supplement Date Received by Manufacturer: 03/10/2023
• Initial Report FDA Received Date: 03/09/2023
• Supplement Report FDA Received Date: 03/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown