MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE SPINAL S/SU 25GA TW 5IN WHITACRE; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Catalog Number	405140
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.H3 other text : see h10 manufacture narrative.
Event or Problem Description
Material#: 405140 lot#: unknown it was reported by customer that ahs received a medical device incident report that involved bd spinal needle (code: 405140) with adverse patient impact/potential adverse patient impact.Verbatim: ahs received a medical device incident report that involved bd spinal needle (code: 405140 )with adverse patient impact/potential adverse patient impact.Hi bd team ahs received a medical device incident report that involved bd spinal needle (code: 405140 )with adverse patient impact/potential adverse patient impact.Ahs mdip number: 38100 date of mdip (yyyy-mm-dd): (b)(6) 2024 adverse effect: harm or potential for clinically serious adverse event device available for investigation: yes reported device: whiteacre pencil point spinal needle reported device manufacturer code: 405140 15feb2024: per customer response: date of incident (yyyy-mm-dd): (b)(6) 2024 what was the type of incident/problem? a2.Failure (i.E.While preparing for, in use, after use) what was the level of harm?: harm or clinically serious adverse event ahs report to health canada: yes what are the details of the incident?: end of spinal needle broke off when removing introducer from patient.Approx 4.5cm retained in patient.Pt was a high bmi.Surgeon had to make incision in patient back to remove spinal needle end.Impact of incident: who was affected? patient did this problem/incident result in unexpected or prolonged care?: yes what is the frequency of this problem?: first time were there other device/incident factors?: was this an invasive procedure? not provided or not applicable what procedure?: spinal for ceasarian section.
Additional Manufacturer Narrative
One sample was received for investigation.Through visual inspection, it is observed the 25ga x 5¿ (blue) needle is used, bent and broken, therefore the incident is confirmed.Due to bent area at the cannula near the breakage, it is likely the breakage occurred during rectification/repositioning.This could increase the risk of needle breakage and therefore it is not recommended.A device history review was performed for lot 3198196, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Possible root cause is associated with possible handling issues.It is important to follow the instructions for use.Instructions for use states as follows: ¿repeated repositioning may increase the risk of needle breakage¿ and ¿remove spinal needle and introducer needle together¿.Product undergoes a series of testing and inspections throughout the manufacturing process the ensure the quality and functionality of the device, including verification the needle is free from damage or defects and all critical dimensions are within specification.Based on the teams investigation we are not able to identify a root cause related to our manufacturing process at this time.
Event or Problem Description
No additional info.
Additional Manufacturer Narrative
(b)(4) - follow up mdr for correction.Following the submission of the initial mdr, it was noted that the incorrect reportability awareness date was used.This date was updated from the initially reported 09feb2023 to the corrected aware date of 15feb2023.
Event or Problem Description
Correction for aware date.See h10.

• Brand Name: NEEDLE SPINAL S/SU 25GA TW 5IN 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 MDS DCHU; 75 north fairway drive; vernon hills IL 60061
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18739029
• Report Number: 2618282-2024-00010
• Device Sequence Number: 6396558
• Product Code: BSP
• UDI-Device Identifier: 30382904051403
• UDI-Public: (01)30382904051403
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 405140
• Device Lot Number: 3198196
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2024
• Supplement Date Received by Manufacturer: 02/15/2024; 03/28/2024
• Initial Report FDA Received Date: 02/20/2024
• Supplement Report FDA Received Date: 03/05/2024; 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female