MAUDE Adverse Event Report: BECTON DICKINSON NOT APPLICABLE; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Catalog Number	405081
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It is reported needle had protruded beyond the sheath.Initial description: the doctor upon opening the spinal needle package, it was found that the needle had protruded beyond the sheath, and it had not been used yet.The needle was inside the sheath within the packaging from the beginning.
Additional Manufacturer Narrative
Two photos were received by our quality team for evaluation.The images show a 27ga (gray) needle along with its components (needle-hub, stylet-handle, and shield).In one photo the needle seems to be bent and in the other photo the needle and/or stylet seem to be damaged.The reported incident could be verified.A device history record review found no non-conformances associated with this issue during production of this batch.Based on the quality team's investigation, the most probable causes of a bent needle and damaged shield are associated with manufacturing when the stylet is assembled to the cannula, the shield is installed onto the cannula, and the components are unloaded from the machine.Additionally, shield damage may occur during manual storage and handling of the needles following assembly.This incident has been added to our database of reported incidents.
Event or Problem Description
No additional information.

• Brand Name: NOT APPLICABLE
• 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: 24035873
• Report Number: 2618282-2025-00154
• Device Sequence Number: 18410729
• Product Code: BSP
• UDI-Device Identifier: 00382904050818
• UDI-Public: (01)00382904050818(17)291130(10)4344681
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K091758
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2026

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: 405081
• Device Lot Number: 4344681
• 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: 12/23/2025
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown