MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD ULTRA-FINE¿ ORIGINAL PEN NEEDLES 29G; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	328203
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is unknown; awareness date has been used for this.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd ultra-fine¿ original pen needles 29g leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: consumer reported injection site is wet when removed after injection.Callers spouse completes injections on him, hold into site for 5 seconds only and has thumb on dose button when inserting the needle into site.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval? yes.D10: returned to manufacturer on: 03-jan-2023.H6: investigation summary customer returned seven pen needle 29ga 12.7mm.Customer reported injection site is wet when removed after injection.Customer discarded used pen needles and returned unused samples.The pen needles were visually inspected and found no issues.All the returned pen needles were tested for clog/flow using pen injector, and no issues were found.The alleged defect could not be confirmed.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 based on the sample received and test performed.The root cause could not be determined because the issue could not be confirmed.
Event or Problem Description
It was reported while using bd ultra-fine¿ original pen needles 29g leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: consumer reported injection site is wet when removed after injection.Callers spouse completes injections on him, hold into site for 5 seconds only and has thumb on dose button when inserting the needle into site.

• Brand Name: BD ULTRA-FINE¿ ORIGINAL PEN NEEDLES 29G
• 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: 15929657
• Report Number: 9616656-2022-01330
• Device Sequence Number: 14552257
• Product Code: FMI
• UDI-Device Identifier: 00382903282036
• UDI-Public: (01)00382903282036
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 02/02/2023

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: Other
• Device Expiration Date: 05/31/2024
• Device Model Number: 328203
• Device Catalogue Number: 328203
• Device Lot Number: 9134785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2022
• Supplement Date Received by Manufacturer: 02/02/2023
• Initial Report FDA Received Date: 12/07/2022
• Supplement Report FDA Received Date: 02/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2019
• 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