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	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/12/2022
Type of Reportable Event	Serious Injury
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 that the bd nano¿ ultra-fine¿ pen needles broke off during injection.The patient visited the er, where tweezers were used to remove the broken piece, and super glue was used to seal the site.The following information was provided by the initial reporter: consumer reported bd nano 4mm pen needle.Stated broke off in site (b)(6) 2022 during injecting.Caller stated visited the emergency room at local hospital.Consumer called back.Informed the er used tweezer to remove the needle and did not complete xrays for this visit.They did use a super glue at this callers site.Caller denied reuse of needles.He placed the needle assembly from this incident in his sharps container.
Additional Manufacturer Narrative
H.6.Investigation summary: a complaint lot history check was performed on lot # 1285791 for breaks off during use pe.This is the 1st.Related complaint for breaks off during use pe on lot # 1285791.No samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.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.Embecta was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.
Event or Problem Description
It was reported that the bd nano¿ ultra-fine¿ pen needles broke off during injection.The patient visited the er, where tweezers were used to remove the broken piece, and super glue was used to seal the site.The following information was provided by the initial reporter: consumer reported bd nano 4mm pen needle.Stated broke off in site (b)(6) 2022 during injecting.Caller stated visited the emergency room at local hospital.- consumer called back.Informed the er used tweezer to remove the needle and did not complete xrays for this visit.They did use a super glue at this callers site.Caller denied reuse of needles.He placed the needle assembly from this incident in his sharps container.

• 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: 15183061
• Report Number: 9616656-2022-00824
• Device Sequence Number: 20421966
• 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: 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,Followup
• Report Date (Section B): 08/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 8975
• Device Catalogue Number: 320883
• Device Lot Number: 1285791
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2022
• Supplement Date Received by Manufacturer: 08/12/2022
• Initial Report FDA Received Date: 08/08/2022
• Supplement Report FDA Received Date: 09/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown