MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE SPINAL S/SU 25GA 3-1/2IN QUINCKE; NEEDLE, SPINAL, SHORT TERM

Catalog Number	405180
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Material #405180 lot #unknown the clinic believes there is a difference with the hubs because the tan one leaks when in use.Verbatim: i have a clinic who is trying to order #405180 through xxxx.The picture on xxxx shows a blue hub, but when they receive the product, it is a tan hub.The clinic believes there is a difference with the hubs because the tan one leaks when in use.We will not be able to give you the used/dirty needles or provide the packaging information as this has been a problem since late 2024.However, we can make a list starting today and going forward.We do many procedures weekly that use these needles.Can you please provide an exact date of event in this format mm-dd-yyyy? can you please provide the lot number associated with reported issue? answers: i do not have specific dates, as there are multiple occasions before dr wanted the leaking reported.I have a chart on the computer that i will be immediately able to write down dates/lot # etc., going forward.This has been ongoing since november 2024.4.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.Answer: the dr stated the needles leak after the stylet is removed and syringe connected.Each time he readjusts the syringe.It is a luer lock syringe.The dr stated he is unsure of the amount of medication being delivered to the spine area of interest due to leakage and dripping onto the sterile field.He trusted bd blue hub needles to not leak.
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.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
One photo was received by our quality team for evaluation.The photo shows a sealed and unopened 25ga (orange) needle facing up in its bister.No catalog, batch number nor expiration date is seen.Based on the photo alone, the reported incident could not be verified.A device history record could not be evaluated as the lot number is unknown.Based on the quality team's investigation, a root cause could not be determined.If a physical sample becomes available, the complaint will be re-opened for further investigation.

• Brand Name: NEEDLE SPINAL S/SU 25GA 3-1/2IN QUINCKE
• Common Device Name: NEEDLE, SPINAL, SHORT TERM
• 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: 22168807
• Report Number: 2618282-2025-00049
• Device Sequence Number: 7798843
• Product Code: MIA
• UDI-Device Identifier: 00382904051808
• UDI-Public: (01)00382904051808
• 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
• Report Date (Section B): 07/15/2025

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: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown