MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; SINGLE SHOT EPIDURAL TRAY

Catalog Number	PAIN1308
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Headache (1880)
Date of Event	05/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the facility the patient experienced a "headache post cervical epidural injection approximately 1-2 days later".
Additional Manufacturer Narrative
According to the facility the patient experienced a "headache post cervical epidural injection approximately 1-2 days later".Per the facility the patient required "caffeine beverages, supine rest, and fioricet tabs".Per the facility they were unable to tell if the component/syringe malfunctioned during use, however, the provider stated they've "never had post spinal leak headaches after cervical epidural injection".No additional information is available at this time.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: SINGLE SHOT EPIDURAL TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes dr; northfield, IL 60093
• MDR Report Key: 19557554
• Report Number: 1417592-2024-00660
• Device Sequence Number: 11974742
• Product Code: OFT
• UDI-Device Identifier: 10888277788770
• UDI-Public: 10888277788770
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/18/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: PAIN1308
• Device Lot Number: 24ALA332
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2024
• Initial Report FDA Received Date: 06/18/2024
• 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