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

Model Number	8975
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical 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.(b)(4).
Event or Problem Description
It was reported that no insulin would flow through the bd ultra-fine¿ insulin pen needle during the priming.The following information was provided by the initial reporter: "consumer reported when priming, no insulin flows, so she has to use a second pen needle to get it to work.Stated, if it does not prime, she will not try to inject with it.".
Additional Manufacturer Narrative
Correction: the lot# has been provided by the customer.The following fields have been updated: d.2.Medical device lot#: 8263492 d.4.Medical device expiration date: 2023-08-31 h.4.Device manufacture date: 2019-01-03.
Event or Problem Description
It was reported that no insulin would flow through the bd ultra-fine¿ insulin pen needle during the priming.The following information was provided by the initial reporter: "consumer reported when priming, no insulin flows, so she has to use a second pen needle to get it to work.Stated, if it does not prime, she will not try to inject with it".
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: 2020-06-22.H.6.Investigation summary customer returned one (1) used 31gx5mm bd pen needle from lot 8263492.Consumer reported when priming, no insulin flows.The returned pen needle was examined, then tested for flow using a test pen injector: the pen needle was able to expel properly.No evidence of manufacturing defect was observed.Since no defects were observed the alleged issue could not be confirmed.Pen needle dhr batch 8263492 was reviewed.The batch number was built on pen needle assembly line in jan 2019.Review of the dhr revealed all required challenges samples and testing was performed per specification in accordance with the in-process sampling plans.No quality notification was raised on past 12 months on similar non-conformance.Bd was not able to duplicate or confirm the customer¿s indicated failure.Root cause cannot be determined at this time as the issue is unconfirmed.
Event or Problem Description
It was reported that no insulin would flow through the bd ultra-fine¿ insulin pen needle during the priming.The following information was provided by the initial reporter: "consumer reported when priming, no insulin flows, so she has to use a second pen needle to get it to work.Stated, if it does not prime, she will not try to inject with it".

• Brand Name: BD ULTRA-FINE INSULIN PEN NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• MDR Report Key: 10182004
• Report Number: 9616656-2020-00574
• Device Sequence Number: 2924638
• Product Code: FMI
• UDI-Device Identifier: 10885403897504
• UDI-Public: 10885403897504
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K162516
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/06/2020

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: 08/31/2023
• Device Model Number: 8975
• Device Catalogue Number: 320882
• Device Lot Number: 8263492
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2020
• Initial Date Received by Manufacturer: 06/02/2020
• Supplement Date Received by Manufacturer: 06/02/2020; 06/02/2020
• Initial Report FDA Received Date: 06/22/2020
• Supplement Report FDA Received Date: 07/06/2020; 08/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other