MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD NANO ULTRA-FINE PEN NEEDLES, 32G X 4MM MAIL ORDER; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	320883
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 while using bd nano¿ ultra-fine¿ pen needles, 32g x 4mm mail order insulin was unable to be completely delivered during injection.The following information was provided by the initial reporter: it was reported that insulin stopped flowing during injection.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 4/30/2021.H.6.Investigation: customer returned a single pen needle with no cap or teardrop label for identification.The pen needle was tested for clogs via simulated use.It was attached to a test pen filled with saline.The pen was primed and saline was pushed through the system.The saline exited the pen needles without any issues.Pen needle dhr batch 9259246 was reviewed.Review of the dhr revealed all required challenges samples and testing was performed per specification in accordance with the in-process sampling plans.As per review it was noted that there were no reject activity findings throughout the build of this lot that would impact upon the quality of the product.No quality notification was raised on past 12 months on similar non-conformance.Root cause cannot be determined at this time as the issue is unconfirmed.
Event or Problem Description
It was reported while using bd nano¿ ultra-fine¿ pen needles, 32g x 4mm mail order insulin was unable to be completely delivered during injection.The following information was provided by the initial reporter: it was reported that insulin stopped flowing during injection.

• Brand Name: BD NANO ULTRA-FINE PEN NEEDLES, 32G X 4MM MAIL ORDER
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 11681891
• Report Number: 8041187-2021-00301
• Device Sequence Number: 3520559
• Product Code: FMI
• UDI-Device Identifier: 00382903208838
• UDI-Public: 00382903208838
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K133532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2021

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: 09/30/2024
• Device Model Number: 320883
• Device Catalogue Number: 320883
• Device Lot Number: 9259246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2021
• Initial Date Received by Manufacturer: 03/21/2021
• Supplement Date Received by Manufacturer: 05/24/2021
• Initial Report FDA Received Date: 04/16/2021
• Supplement Report FDA Received Date: 06/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1