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 Code	Separation Problem (4043)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	08/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.Date of event is unknown; awareness date has been used for this field.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 the outer shield did not properly detach.There was no report of patient impact.The following information was provided by the initial reporter: consumer reported finding the outer cover to fall off the needle hub when placed into her travel sharps continer.She transfered the smaller container to the larger sharps containter and pricked her finger a few times.No medical attention needed.Just a stick under skin no blood.Informed caller to leave the sharps in container never remove from one to the other.Consumer reported found 1 pen needle (b)(6) 2023 last night when removed from pen turned needle off after use slided the cover off pen needle, but the cover only came away needle stayed on the pen after she had turned it several times.Caller is visual impaired.
Event or Problem Description
It was reported while using bd ultra-fine¿ nano¿ pen needles 4mm (5/32¿) 32g the outer shield did not properly detach.There was no report of patient impact.The following information was provided by the initial reporter: consumer reported finding the outer cover to fall off the needle hub when placed into her travel sharps continer.She transfered the smaller container to the larger sharps containter and pricked her finger a few times.No medical attention needed.Just a stick under skin no blood.Informed caller to leave the sharps in container never remove from one to the other.Consumer reported found 1 pen needle on (b)(6) 2023 last night when removed from pen turned needle off after use slided the cover off pen needle, but the cover only came away needle stayed on the pen after she had turned it several times.Caller is visual impaired.
Additional Manufacturer Narrative
H.6 investigation summary no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.This is the 1st complaint for the reported lot number.A review of the manufacturing records was performed, and no non-conformances were raised in association with this type of event for this lot.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.

• 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: 17666745
• Report Number: 9616656-2023-00954
• Device Sequence Number: 12543648
• Product Code: FMI
• UDI-Device Identifier: 10885403928659
• UDI-Public: (01)10885403928659
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2024

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: 2040040
• 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: 08/31/2023
• Initial Report FDA Received Date: 08/31/2023
• Supplement Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/19/2022
• 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