MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	320122
Medical Device Problem Codes	Leak/Splash (1354); Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E.1.Address information was not able to be obtained, therefore, nj was used as a place holder.H.3.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¿ nano¿ pen needles 4mm (5/32¿) 32g leakage occurred and the shield was not properly removed.There was no report of patient impact.The following information was provided by the initial reporter: from phone call on (b)(6) 2023 12:38:40: consumer returned rep's call.She stated that the insulin is leaking through the hub.Consumer is new to using pen needles.After reviewing the steps for attaching the needles, it was realized that the consumer was not removing the inner shield.Date of event is (b)(6), not (b)(6).Using bd (pen needle 4mm nano 32g) the customer noticed seeping from the needle (b)(6) 2023 (no time given).
Additional Manufacturer Narrative
Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot.
Event or Problem Description
It was reported while using bd ultra-fine¿ nano¿ pen needles 4mm (5/32¿) 32g leakage occurred and the shield was not properly removed.There was no report of patient impact.The following information was provided by the initial reporter: from phone call on 2023-08-14 12:38:40: consumer returned rep's call.She stated that the insulin is leaking through the hub.Consumer is new to using pen needles.After reviewing the steps for attaching the needles, it was realized that the consumer was not removing the inner shield.Date of event is august 9th, not august 3rd.Using bd (pen needle 4mm nano 32g) the customer noticed seeping from the needle aug.3, 2023 (no time given).

• Brand Name: BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G
• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17658870
• Report Number: 9616656-2023-00945
• Device Sequence Number: 6306396
• Product Code: FMI
• UDI-Device Identifier: 10885403928659
• UDI-Public: (01)10885403928659
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K933545
• 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): 09/14/2023

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 Catalogue Number: 320122
• Device Lot Number: 3017794
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2023
• Supplement Date Received by Manufacturer: 09/07/2023
• Initial Report FDA Received Date: 08/31/2023
• Supplement Report FDA Received Date: 09/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2023
• 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