MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BD NOKOR FILTER NEEDLE WITH 5 MICRON FILTER 18G X 1 1/2 TW; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Catalog Number	305201
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A pharmacy technician working in the clean room brought a concern to me that she discovered after opening what she thought was a bd precisionglide needle 18g x 1 1/2" tw package and attaching the needle to a syringe.She noticed a filter attached which cause her to take a second look at the packaging and discover the needle was actually a bd nokor filter needle with 5 micron filter 18g x 1 1/2 tw.She looked in all areas of the pharmacy where needles are stored and found several areas in which these products were mixed.They have the same shade of pink strip across the bottom of the packaging, the only noticeable (albeit barely) difference between the packages is the product name.The hub of the needles are also similar shades that may be able to discern when not side by side.We removed these filter needles from the pharmacy and alerted our distribution department.We are concerned that since both types of needles are stocked in our crash trays that they could be easily swapped for one another in a high-risk situation.Ismp is a federally certified patient safety organization and ad fda medwatch partner ismp, 5200 butler pike, plymouth meeting, pa 19462 / phone:215-947-7797 / email: merp@ismp.Org.Submission id: (b)(4).

• Brand Name: BD NOKOR FILTER NEEDLE WITH 5 MICRON FILTER 18G X 1 1/2 TW
• Common Device Name: NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY
• MDR Report Key: 20098285
• Report Number: MW5159010
• Device Sequence Number: 20749331
• Product Code: GAA
• UDI-Device Identifier: 00382903052011
• UDI-Public: (01)00382903052011
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date (Section B): 07/25/2024

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
• Device Catalogue Number: 305201
• Device Lot Number: 3236173
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/28/2024
• Patient Sequence Number: 1
• Patient Sex: Unknown