MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE SPINAL S/SU 22GA 1-1/2IN QUINCKE; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Catalog Number	405161
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2024
Type of Reportable Event	Malfunction
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
Material # 405161.Batch # unknown.Verbatim: "in the past we could use one needle and switch the syringe out with the three injections: lidocaine, omnipaque 300, and the steroid.It is being reported that they are having issues with the needle after the omnipaque is injected." customer response received on (b)(6)2025.1.Could you please provide a further description of the issue? what kind of issue they were faced? difficulty administering steroid through 25g bd 1.5¿ needles for steroid joint injections.I have been using these needles for greater than one year for joint injections.Recently in the last month, i will get the needle in place, inject omnipaque 300 through the needle to confirm correct needle placement and then go to inject the steroid and will be unable to push anything through the needle.I have been doing the same technique with the same equipment and the same medications for greater than one year.It was just over the past month or so that this problem has arisen.2.Can you please provide an exact date of event in this format mm-dd-yyyy? approximately from the end of (b)(6) 2024 to present day.3.Please share the lot number associated with reported issue 3209585.4.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.This results in a larger needle being used than necessary and a second needle puncture to the joint.5.Any physical sample available for investigation? if yes, please provide the address of the facility for us to ship the return label? yes.(b)(6).6.Please share the captured photo of the event if available.N/a.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation results: wo (2) 22ga x 1.5¿ unused and sealed needles for batch number 3013711 were received by our quality team for evaluation.The samples were submitted to inspection for visual characteristics point quality.No point damage; including hooks, swage marks, scratches, incomplete or open points, unsmooth ground surfaces, discoloration of any kind or silvers; no protruders, and no receders were observed.The needles were also submitted for testing.The samples comply with the expected characteristics; therefore, the reported failure was not verified.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, a root cause could not be determined as the failure was not verified.

• Brand Name: NEEDLE SPINAL S/SU 22GA 1-1/2IN 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
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 21133537
• Report Number: 2618282-2025-00001
• Device Sequence Number: 7582739
• Product Code: BSP
• UDI-Device Identifier: 00382904051617
• UDI-Public: (01)00382904051617
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K210978
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2025

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: 405161
• Device Lot Number: 3013711
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2024
• Supplement Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 01/11/2025
• Supplement Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown