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

Catalog Number	405138
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/29/2025
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 # 405138, batch # 4304716.It was reported by customer that when advancing spinal needle, it separated and was lodged in the pts spinal.Verbatim: rcc received a complaint via phone.Pir attached.Issue: when advancing spinal needle, it separated and was lodged in the pts spinal colomn.Pt did require diganositcs and surger to remove the other end.Pt harm: yes.
Event or Problem Description
Additional information: the patient was in our labor and delivery unit when receiving the epidural.The patient needed surgery to remove this needle that was lodged into her spine.
Additional Manufacturer Narrative
Samples received by our quality team for investigation were not bd spinal needles; therefore, a sample analysis could not be performed.A review of the internal manufacturing device records 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, a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: NEEDLE SP S/SU 25GA TW 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: 22086972
• Report Number: 2618282-2025-00042
• Device Sequence Number: 8060150
• Product Code: BSP
• UDI-Device Identifier: 00382904051389
• UDI-Public: (01)00382904051389(11)250210(17)291031(10)4304716
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K210978
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 405138
• Device Lot Number: 4304716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown