MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE CONVENIENCE KIT; SPINAL TRAY

Catalog Number	PAIN1393
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the facility, the "anesthesiologist states that he was performing the spinal block injection for a c-section.There was good csf return before and after the injection.After 10 minutes, the patient was only slightly numb in the lower limbs and toes.Not enough to perform the procedure.The provider proceeded by performing an epidural, and the c -section was performed.There was no patient harm during this process, but it delayed the procedure by an hour due to troubleshooting".The provider is questioning whether the correct medication was in the tray.There was no further information.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, 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 "anesthesiologist states that he was performing the spinal block injection for a c-section.There was good csf return before and after the injection.After 10 minutes, the patient was only slightly numb in the lower limbs and toes.

• Brand Name: MEDLINE CONVENIENCE KIT
• Common Device Name: 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: 24424432
• Report Number: 1417592-2026-00140
• Device Sequence Number: 12246954
• Product Code: OJH
• UDI-Device Identifier: 10193489629965
• UDI-Public: 10193489629965
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 02/23/2026

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
• Device Catalogue Number: PAIN1393
• Device Lot Number: 25HMB657
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/07/2025
• 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: Female