MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE SP S/SU 25GA TW5IN WHITACRE CE; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Catalog Number	400373
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Needle broke in patients back - patient had to have surgery to remove the needle.
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.
Additional Manufacturer Narrative
Sample and photos received by our quality team for investigation.Through visual inspection, a portion of a spinal needle was received loose inside of a round, white cylinder container.It is observed a portion of a needle, a bend in the steel is seen.In the photos, it is observed an unused 25ga (blue hub) needle beside the broken needle missing 4cm of steel, also is seen the tyvek with the catalog, batch number and expiration date.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.Based on product intended use; thinner gages are recommended to be used with an introducer needle in which assists in the placement of spinal needles.It is important to follow the instructions for use.Care should be taken to avoid needle damage.Not attempting to straighten a bent needle.Repeated positioning may increase the risk of needle breakage and therefore it is not recommended.Observe needle carefully during procedures and to be used by properly qualified and trained health professionals.Based on the available information we are not able to identify a root cause related to our manufacturing process at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: NEEDLE SP S/SU 25GA TW5IN WHITACRE CE
• 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: 20571102
• Report Number: 2618282-2024-00152
• Device Sequence Number: 15496370
• Product Code: BSP
• UDI-Device Identifier: 00382904003739
• UDI-Public: (01)00382904003739
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K210978
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2024

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: 400373
• Device Lot Number: 3360740
• 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: 10/29/2024
• Supplement Date Received by Manufacturer: 11/27/2024
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2024
• 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: Unknown