MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD ULTRA-FINE¿ MICRO PEN NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	72213N
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an unspecified number of bd ultra-fine¿ micro pen needles experienced the inner shield being unable to attach.The following information was provided by the initial reporter: wife of consumer reported sometimes, when attaching to pen, can feel the non patient end does not screw onto the pen straight.She removes and adjusts to place the needle back on pen.
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that an unspecified number of bd ultra-fine¿ micro pen needles experienced the inner shield being unable to attach.The following information was provided by the initial reporter: wife of consumer reported sometimes, when attaching to pen, can feel the non patient end does not screw onto the pen straight.She removes and adjusts to place the needle back on pen.
Additional Manufacturer Narrative
D10: device available for eval yes, d10: returned to manufacturer on: 03-jan-2023 h6: investigation summary customer returned a total of 22 used 4mm, 32 gauge nano pro pen needles.No teardrop labels were provided for lot identification.The pen needles were visually inspected prior to testing.10 of the pen needles were found to have bent needles on the non-patient side of the hub¿s needle cannula.Additionally, 12 were broken on the same side.This damage would prevent testing for clogs since the needle cannot properly attach to the pen.As a result, the pen needles appear to be clogged during use.Based on the damage present, the needles bending or breaking 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.A device history review could not be completed as no batch number was provided.Based on the samples received, embecta found that 10 pen needles had become bent and 12 had been broken on the non-patient side.This damage could resemble the needle being clogged as a result of insulin not passing through the needle.The root cause of the needles bending and breaking appears to be accidental damage from stresses caused by the user during routine use.This would have also given the impression that the needle was clogged since insulin would be unable to pass through the cannula.

• Brand Name: BD ULTRA-FINE¿ MICRO PEN NEEDLE
• 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 ; 8015296192
• MDR Report Key: 15939063
• Report Number: 9616656-2022-01333
• Device Sequence Number: 15002725
• Product Code: FMI
• UDI-Device Identifier: 07613203010078
• UDI-Public: 07613203010078
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K213478
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2023

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: 72213N
• Device Catalogue Number: 320749
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2022
• Supplement Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 12/08/2022
• Supplement Report FDA Received Date: 03/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown