MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE SPINAL S/SU 20GA 6IN QUINCKE; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Catalog Number	405211
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	06/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material # 405211.Batch # 4045038.It was reported by customer that needle breaking off inside of hub.Verbatim: rcc received a complaint via email.Email(s) attached.Rep xxxxxx emailed to report product b-d405211z breaking off inside of hub.Customer is requesting credit for 1 bx of item.
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.
Additional Manufacturer Narrative
No samples or photos received for investigation.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.It is important to follow the instructions for use: with any spinal procedure to help avoid needle breakage: do not attempt to straighten a bent needle.Care should be taken to avoid needle damage.Repeated positioning may increase the risk of needle breakage.Observe needle carefully during procedures.Remove spinal needle and introducer needle together.Replace with a new needle.Based on the quality team's investigation, we are not able to identify a root cause related to our manufacturing process at this time.
Event or Problem Description
No additional information.

• Brand Name: NEEDLE SPINAL S/SU 20GA 6IN 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: 20075042
• Report Number: 2618282-2024-00116
• Device Sequence Number: 20460042
• Product Code: BSP
• UDI-Device Identifier: 00382904052119
• UDI-Public: (01)00382904052119(11)240318(17)290131(10)4045038
• 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): 09/20/2024

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: 405211
• Device Lot Number: 4045038
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2024
• Supplement Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown