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

Catalog Number	405180
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.
Event or Problem Description
It was reported that bd unknown product leaked.It was reported by customer that they have two more incidents on a list of leaking.Rcc received a complaint via email.I do have 2 more incidents on a list of leaking dates/lot #.However, i didn't know of the time limit to keep the complaint open.I will contact you again if the provider agrees to reopening the case.
Additional Manufacturer Narrative
Follow up mdr for additional information.See b tab.Correction: see d tab.Manufacturing location: bd caribe.510k: k210978.Annex f code updated.
Event or Problem Description
Additional information 1.As mentioned, there are two more incidents related to leakage.Could you please provide the exact dates of these events in the mm-dd-yyyy format? (b)(6) 2025.2.Please share the material & lot number associated with reported issue lot # is the same for both dates.Came from the same box.4267390.Sku# 405180.Bd 25g x 3.5" quincke spinal needles.3.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.No patient harm/injury.Complication/negative outcome is that the with the leaking hub area, the provider feels that the full dosage of the medication did not reach the intended area.The provider does readjust the syringe/needle connection to verify full contact is in tact.(b)(6) 2025 patient was a cervical median branch block.(b)(6) 2025 patient was a lumbar median branch block.4.Any physical sample available for investigation? if yes, please provide the address of the facility for us to ship the return label? no physical sample is available as used/dirty needles are placed in the sharps bucket after the procedure.5.How many patients were affected by the reported leaks? 2.6.Are individual event dates available for each of the reported occurrences? if yes, please provide the dates.(b)(6) 2025.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
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.

• Brand Name: NEEDLE SPINAL S/SU 25GA 3-1/2IN QUINCKE
• 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 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 22717097
• Report Number: 2243072-2025-00946
• Device Sequence Number: 15745513
• Product Code: BSP
• UDI-Device Identifier: 00382904051808
• UDI-Public: (01)00382904051808(17)290831(10)4257390
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 09/03/2025

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: 405180
• Device Lot Number: 4257390
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2025
• Supplement Date Received by Manufacturer: Not provided; 09/03/2025
• Initial Report FDA Received Date: 08/05/2025
• Supplement Report FDA Received Date: 08/11/2025; 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown