MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE SPINAL S/SU 27GA 3-1/2IN WHITACRE; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Catalog Number	405079
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2024
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
Needle stuck when trying to remove from sheath (see picture).Needle resistance when trying to insert into introducer.Scratching feeling when removing from introducer which blunts the needle.Old packaging of 405079 (batch: 1120615) does not have above problem, put together in box for reference and comparison.405260 introducer needle put together for testing scratching sound.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation results: ten samples were received by our quality team for evaluation.Nine 27ga x 3.5¿ needles were from batch 4183543, the lot with the reported issue.Out of the nine, four needles were unused and sealed in their blister and five needles were out of the blisters.One 27ga x 3.5¿ unused and sealed needle for batch 1120615, the lot that was reported to not have the issue, and the introducer was also received.It was observed that the needles had their components (needle, stylet and shield).The samples were submitted for visual inspection and testing.One of the opened needles from the reported lot, 4183543, was bent at the tip of the hub which was preventing full insertion of the stylet; therefore, the reported incident could be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections related to this incident were found.Based on the quality team's investigation, the reported issue was due to the bent needle.The root cause of the bent needle is potentially related to handling issues as there were no issues with the unused samples provided.As it is explained in the ifu, care should be taken to avoid needle damage.This incident has been added to our database of reported incidents.

• Brand Name: NEEDLE SPINAL S/SU 27GA 3-1/2IN WHITACRE
• 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: 21138370
• Report Number: 2618282-2025-00002
• Device Sequence Number: 20540447
• Product Code: BSP
• UDI-Device Identifier: 00382904050795
• UDI-Public: (01)00382904050795(11)240808(17)290630(10)4183543
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K210978
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2025

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: 405079
• Device Lot Number: 4183543
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2024
• Supplement Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/08/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown