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	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported bd nano ultra-fine pen needle were unable to prime.The following information was provided by the initial reporter: ".Finds pen needles to be clogged during flow check.".
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary: customer returned a single used 4mm, 32 gauge nano pro pen needle.No teardrop label was returned for lot confirmation.The patient end of the cannula of the pen needle was bent at its base, then again approximately 3mm from its tip, then again approximately 1mm from its tip.Despite the damage, the pen needle was still capable of priming and ejecting a saline solution when attached to a test pen.It was noted during testing that the needle remained in place despite the damage sustained and could not be dislodged when in contact with a skin analog during simulated use.Pen needle dhr batch 0134148 was reviewed.The batch number was built with pen needle assembly line in nov 2020.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.Based on the sample received, bd was able to confirm the customer¿s indicated failure of the needle being bent.Bd was unable to replicate or confirm the customer¿s indicated failure of the pen needle being difficult to operate.Bd was unable to replicate or confirm the customer¿s indicated failure of the needle being clogged.H3 other text : see h10.
Event or Problem Description
It was reported bd nano ultra-fine pen needle were unable to prime.The following information was provided by the initial reporter: ".Finds pen needles to be clogged during flow check.".

• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12869897
• Report Number: 9616656-2021-01455
• Device Sequence Number: 20318896
• 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): 12/02/2021

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: 06/30/2025
• Device Model Number: 8975
• Device Catalogue Number: 320883
• Device Lot Number: 0134148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2021
• Supplement Date Received by Manufacturer: 12/02/2021
• Initial Report FDA Received Date: 11/24/2021
• Supplement Report FDA Received Date: 12/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2020
• 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