MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE SPINAL S/SU 22GA 3-1/2IN QUINCKE; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Catalog Number	405181
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2024
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# 405181 batch# 4123761 verbatim: i have a handful of these needles.Ref 405181 22g x 3.50¿ lot# 4123761 i am told that these have been ¿clogging up¿ when being used.Three different staff members have stated this.Additional information: dec 20 it happened multiple time (3+) for 3 different radiologists on 3 different days.No patient harm.
Additional Manufacturer Narrative
Investigation results: three (3) 22ga x 3.5¿ unused and sealed needles for batch number 4123761 were received by our quality team for evaluation.The samples were submitted for visual inspection first.There was no point damage, including hooks, swage marks, scratches, incomplete or open points, unsmooth ground surfaces, discoloration of any kind or silvers, and no protruders, no receders.The needles were also submitted to test for any clogs or blockages.The samples comply with the expected characteristics and the reported failure was not observed in the needles; therefore, the reported failure could not be 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 incident could not be verified.
Event or Problem Description
No additional information.

• Brand Name: NEEDLE SPINAL S/SU 22GA 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
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 21056118
• Report Number: 2618282-2024-00194
• Device Sequence Number: 18129629
• Product Code: BSP
• UDI-Device Identifier: 00382904051815
• UDI-Public: (01)00382904051815(11)240520(17)290430(10)4123761
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 01/23/2025

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: 405181
• Device Lot Number: 4123761
• 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: 12/20/2024
• Supplement Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown