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

Catalog Number	405079
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Event details: a piece of item # 405079 x 1 ea lot # 4242354 broke in a patient¿s back.Information below: patient status = o.K., they retrieved the piece from the patient no samples available to return ¿ the remaining units from the lot discarded (the piece was also not available) can you please provide an exact date of the event in the format dd-mmm-yy? 30-09-2025 was additional surgery needed to remove the broken needle? yes, an orthopedist came to remove the needle.Has the initial procedure been completed? no, the planned surgery had to be postponed.
Additional Manufacturer Narrative
Initial mdr, if a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Investigation results: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident, therefore a root cause could not be determined.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Per investigation performed, current controls are adequate to mitigate risks associated to the reported failure.
Event or Problem Description
No additional information.

• Brand Name: NEEDLE SPINAL S/SU 27GA 3-1/2IN WHITACRE
• Common Device Name: NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos PR
• 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: 23413340
• Report Number: 2618282-2025-00116
• Device Sequence Number: 13018822
• Product Code: BSP
• UDI-Device Identifier: 00382904050795
• UDI-Public: (01)00382904050795(17)290831(10)4242354
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2025

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: 405079
• Device Lot Number: 4242354
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/02/2024
• 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