MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE SPINAL S/SU 25GA 3-1/2IN QUINCKE; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Catalog Number	405180
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
Material: 405180, batch#:4278395.Verbatim: i have a sharps container full of needles from this site that do not inject.(according to the doctor) i have not tested them as they are in a sharps container and i don¿t have the proper equipment to open it safely.No adverse event has occurred or patient injury noted just inconvenient, time wasting and adds a poke to the patient which is not ideal practice.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Following the submission of the initial mdr, it was determined that this complaint is a duplicate of pr (b)(4) and the complaint will be cancelled.The associated mdr will be void.

• Brand Name: NEEDLE SPINAL S/SU 25GA 3-1/2IN QUINCKE
• Common Device Name: NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos PR
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 21434586
• Report Number: 2618282-2025-00013
• Device Sequence Number: 14629672
• Product Code: BSP
• UDI-Device Identifier: 00382904051808
• UDI-Public: (01)00382904051808(11)241029(17)290930(10)4278395
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2025

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: Health Professional
• Device Catalogue Number: 405180
• Device Lot Number: 4278395
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2025
• Supplement Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown