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	Missing Information (4053)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.Date of event is unknown; awareness date has been used for this field.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.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 label had incorrect information.There was no report of patient impact.The following information was provided by the initial reporter: consumer reported that she received a demo box of nano pen needles.She stated that the box has ewo written on it and the tear drop labels are pink and there are no needles attached.
Additional Manufacturer Narrative
The following fields have been updated due to additional information: d.9.Device available for eval?: yes, d.9.Returned to manufacturer on: 08-sep-2023.H.6.Investigation summary: samples received and an investigation was performed.Embecta was able to duplicate or confirm the indicated issue.Complaints received for this device and reported condition will continue to be tracked and trended.The following root causes were identified for the investigated issue based on the completed root cause analysis: use of commercial shelf cartons for packaging of ewo products.Improper fulfilment product receiving process that allowed non-commercial ewo products to get into secured fulfillment inventory unhindered.Lack of detailed ewo labeling requirements in global ewo procedures (b)(4) and local dl ewo procedure (b)(4) to ensure that ewo product labeling provides clear differentiations from commercial products on all product packaging / labeling levels unless commercial packaging and / or labeling components are required for the intended use of ewo products.Lack of requirements in fulfilment process procedure cs-045 for verification of product information on the devices selected for fulfilment.Capa 8408884 was raised to address this issue.
Event or Problem Description
It was reported while using bd ultra-fine¿ nano¿ pen needles 4mm (5/32¿) 32g the label had incorrect information.There was no report of patient impact.The following information was provided by the initial reporter: consumer reported that she received a demo box of nano pen needles.She stated that the box has ewo written on it and the tear drop labels are pink and there are no needles attached.

• 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: 17446899
• Report Number: 9616656-2023-00820
• Device Sequence Number: 20648149
• Product Code: FMI
• UDI-Device Identifier: 10885403928659
• UDI-Public: (01)10885403928659
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K213478
• 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): 09/07/2023

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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/28/2023
• Initial Report FDA Received Date: 08/02/2023
• Supplement Report FDA Received Date: 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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