MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; 25G WHITACRE SPINAL TRAY

Catalog Number	DYNJRA1740A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the facility on 10/28, a 25-gauge 3.5-inch whitacre needle fractured during a spinal block placement at (b)(6) and the remnant remained in patient.
Additional Manufacturer Narrative
According to the facility on 10/28, a 25-gauge 3.5-inch whitacre needle fractured during a spinal block placement at (b)(6) and the remnant remained in patient.Needle used came from a medline spinal anesthesia tray.The patient was transferred to (b)(6) for a neurosurgical evaluation and removal of the needle fragment.The needle was removed successfully.The facility stated it is not aware of any serious injury or significant impact to the patient other than the subsequent procedure to remove the needle.It has been determined that the reported event caused or contributed to serious injury requiring medical intervention, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the facility, the whitacre needle within the kit broke inside the patient and required a secondary surgery to retrieve the needle from their back.
Additional Manufacturer Narrative
According to the facility, the whitacre needle within the kit broke inside the patient and required a secondary surgery to retrieve the needle from their back.No additional information is available.Due to the reported incident and in an abundance of caution, this is a reportable event.It has been determined that the reported event caused or contributed to serious injury requiring medical intervention, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Common Device Name: 25G WHITACRE SPINAL TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 20756963
• Report Number: 1417592-2024-00974
• Device Sequence Number: 9264150
• Product Code: OJH
• UDI-Device Identifier: 40195327088935
• UDI-Public: 40195327088935
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2024

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?: No
• Device Catalogue Number: DYNJRA1740A
• Device Lot Number: 24GMJ821
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2024
• Supplement Date Received by Manufacturer: 12/03/2024
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown