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	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported connection issue with needle and syringe.Event details: the needle does not fit properly with the different syringes that were tested, resulting in leakage during the administration of the medication in this case for anesthesia.Additional information could you please confirm if the different syringes tested are from bd? yes.Could you please provide the syringe catalog and lot number? 4134412.Could you please clarify this matching problem using the same or different product catalogs? no.Is there any impact for the patient? yes.Provide details of the impact/harm to the patient? detected prior to administration was there exposure to blood or chemotherapy on mucous membranes or skin (detail)? no.
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.
Additional Manufacturer Narrative
Two photos and one physical sample were received by our quality team for evaluation.The sample was submitted for inspection for visual characteristics and testing.The inspection was executed, and the sample complies with the expected characteristics, the reported failure of connectivity issue was not observed in the sample and could not 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, a root cause could not be determined as the incident could not be verified.Bd devices are designed to be molded components compatible with iso594 dimensions.Therefore, it is recommended to use syringes compatible with iso standards.This incident has been added to our database of reported incidents.
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): 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: 22410750
• Report Number: 2618282-2025-00058
• Device Sequence Number: 9673069
• Product Code: BSP
• UDI-Device Identifier: 00382904050795
• UDI-Public: (01)00382904050795(17)290430(10)4134412
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K210978
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2025

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: 4134412
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2025
• Supplement Date Received by Manufacturer: 09/08/2025
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown