MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD NANO¿ ULTRA-FINE¿ 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	02/11/2022
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 nano¿ ultra-fine¿ pen needle would not function.The following information was provided by the initial reporter: consumer reported, some pen needles will not attach to insulin pen.
Event or Problem Description
It was reported that the bd nano¿ ultra-fine¿ pen needle would not function.The following information was provided by the initial reporter: consumer reported, some pen needles will not attach to 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: 07-mar-2022.Investigation summary: customer returned 1 used and 2 unused 4mm, 32 gauge nano pen needles from lot 1138245.The used pen needle was found to have bent needles on the non-patient side of the hub¿s needle cannula.Based on the damage present, the cannula bending most likely prevented the pen from attaching properly.This may be a result of attempting to attach the pen needle if it was not properly aligned with the cannula.The remaining pen needles could be attached to and detached from a pen without issues.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, bd found that the used pen needle had a bent cannula on the non-patient side, preventing the pen from being attached to the pen needle.The root cause of the needle bending appears to be accidental damage from stresses caused by the user by accidentally inserting and tightening the pen needle into place at an angle during routine use.H3 other text : see h10.

• Brand Name: BD NANO¿ ULTRA-FINE¿ 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: 13590618
• Report Number: 9616656-2022-00222
• Device Sequence Number: 3860291
• Product Code: FMI
• UDI-Device Identifier: 10885403897511
• UDI-Public: 10885403897511
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K162516
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2022

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: Lay User/Patient
• Device Expiration Date: 05/31/2026
• Device Model Number: 8975
• Device Catalogue Number: 320883
• Device Lot Number: 1138245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2022
• Supplement Date Received by Manufacturer: 03/30/2022
• Initial Report FDA Received Date: 02/24/2022
• Supplement Report FDA Received Date: 04/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2021
• 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