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

Model Number	8975
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd nano¿ ultra-fine¿ pen needle was clogged while priming.The following information was provided by the initial reporter: consumer reported needle during priming, stated that there is no insulin flow.
Additional Manufacturer Narrative
Investigation summary: customer returned (2) open 32gx4mm bd pen needles without tear drop labels or inner shields attached.The customer reported no insulin flow.The samples were examined, and it was observed that 1 pen needle featured a bent non-patient end (npe) cannula and 1 pen needle featured a broken npe cannula.The bent and broken npe cannulas would prevent proper flow through the pen needles, hence, the customer would think the pen needles were clogged.Since the samples were returned after use, the probable cause of the bent and broken npe cannulas is user error when attaching the pen needles to a pen injector.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 and/or photo(s) received the investigation concluded: confirmed: embecta was able to duplicate or confirm the customer¿s indicated failure (npe cannula bent, npe cannula broken) complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.The root cause for this issue is user related.The npe cannulas were bent and broken after the user handled the pen needles.Based on the above, no additional investigation and no capa/sa is required at this time.

• Brand Name: BD NANO¿ ULTRA-FINE¿ PEN NEEDLES
• 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: 15163601
• Report Number: 9616656-2022-00802
• Device Sequence Number: 14920682
• Product Code: FMI
• UDI-Device Identifier: 10885403897511
• UDI-Public: 10885403897511
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/06/2022

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 Model Number: 8975
• Device Catalogue Number: 320883
• Device Lot Number: 1327879
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2022
• Initial Report FDA Received Date: 08/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2021
• 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