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	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/30/2025
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#:4123754.Verbatim: ahs mdip # 2527 resident was performing a spinal anesthetic on a patient in the holding area prior to surgery.When they removed the needle, they noticed the stilette was missing.Upon closer inspection, you could see that there was a metal stub at the base of the orange hub but the ~3inch long stilette was missing.A full search was performed and it was not located.A flat plate x-ray was performed and it was not seen on x-ray, nor was it seen on ct.At this point, patient was cleared for surgery and surgery proceeded, delayed from earlier.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event? none reported.Delayed surgery time.
Additional Manufacturer Narrative
Investigation results: two samples were received by our quality team for evaluation.Upon inspection, one needle met the expected specification characteristics, while the other had a broken/missing molded handle key and a broken handle off the stylet.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 root cause could either be traced to manufacturing during assembly or during handling of the product.This incident has been added to our database of reported incidents.
Event or Problem Description
No additional information.

• 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: 21421491
• Report Number: 2618282-2025-00011
• Device Sequence Number: 12703586
• Product Code: BSP
• UDI-Device Identifier: 00382904051389
• UDI-Public: (01)00382904051389(11)240520(17)290430(10)4123754
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K210978
• 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): 04/17/2025

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: 4123754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2025
• Supplement Date Received by Manufacturer: 04/17/2025
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2024
• 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