MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; TRAY, 25G WHIT SPINAL W/PHARM

Catalog Number	DYNJRA9034
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility on 1/27, "the incident that occurred on (b)(6) 2025 at (b)(6), involving a patient during an attempted spinal epidural procedure performed by the anesthesia provider.During the procedure, the provider introduced a 25g spinal needle/introducer into the patient's back.When the needle met resistance from the bone, it was withdrawn in an attempt to "walk" the needle off the bone to locate the center of the vertebral space.After several attempts, the needle/introducer was pulled back to reposition it, at which point the needle broke off a few centimeters from the connection to the plastic hub and became retained in the patient's back.As a result, the patient was transported to a local hospital for the removal of the retained needle from the lumbar area.The patient remained stable throughout the process and was discharged from the hospital same day, (b)(6) 2025".The facility stated this was a surgical procedure.A sample is not available for evaluation.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 on 1/27, "the incident that occurred on (b)(6) 2025 at (b)(6), involving a patient during an attempted spinal epidural procedure performed by the anesthesia provider.During the procedure, the provider introduced a 25g spinal needle/introducer into the patient's back.".

• Common Device Name: TRAY, 25G WHIT SPINAL W/PHARM
• 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: 21411022
• Report Number: 1417592-2025-00091
• Device Sequence Number: 15816496
• Product Code: OJH
• UDI-Device Identifier: 10193489467574
• UDI-Public: 10193489467574
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Report Date (Section B): 02/19/2025

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: DYNJRA9034
• Device Lot Number: 24IBU377
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 02/19/2025
• 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 Age: 69 YR
• Patient Sex: Female
• Patient Weight: 101 KG