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

Model Number	8975
Medical Device Problem Code	Misconnection (1399)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2022
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.
Event or Problem Description
It was reported that the bd ultra-fine¿ nano pen needle was unable to attach to the pen.The following information was provided by the initial reporter: consumer reported that the pen needle will not attach to the insulin pen.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 09-nov-2022.H6: investigation summary customer returned a total of 38 used 4mm, 32 gauge nano pen needles.No teardrop labels were returned for lot identification.30 of the pen needles were visually inspected prior to testing.24 of the pen needles were found to have bent needles on the non-patient side of the hub¿s needle cannula.This damage would prevent proper attachment of the pen needle.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 samples were attached to a test pen without issue.No damage found and the samples functioned as intended.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 24 pen needles had become bent on the non-patient side.This damage would result in the pen needle not attaching properly to the pen.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.
Event or Problem Description
It was reported that the bd ultra-fine¿ nano pen needle was unable to attach to the pen.The following information was provided by the initial reporter: consumer reported that the pen needle will not attach to the insulin pen.

• Brand Name: BD ULTRA-FINE¿ NANO 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: 15584275
• Report Number: 9616656-2022-01103
• Device Sequence Number: 6470294
• Product Code: FRN
• UDI-Device Identifier: 10885403897511
• UDI-Public: 10885403897511
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 12/27/2022

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: Other
• Device Model Number: 8975
• Device Catalogue Number: 320883
• Device Lot Number: 2019510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2022
• Supplement Date Received by Manufacturer: 12/27/2022
• Initial Report FDA Received Date: 10/11/2022
• Supplement Report FDA Received Date: 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2022
• 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