MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; DBD-INTERLAMINAR TRAY

Catalog Number	PAIN2173
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	03/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the facility on 3/3 during a c6-7 interlaminar epidural steroid injection, "the extension was used to add contrast into the epidural space.Dr.(b)(6) then attempted to disconnect the extension from the tuohy needle placed in the patient, when he attempted to disconnect the extension would get "stuck" in the needle causing the tuohy needle to slightly move causing a spinal tap".
Additional Manufacturer Narrative
According to the facility on 3/3 during a c6-7 interlaminar epidural steroid injection, "the extension was used to add contrast into the epidural space.Dr.(b)(6) then attempted to disconnect the extension from the tuohy needle placed in the patient, when he attempted to disconnect the extension would get "stuck" in the needle causing the tuohy needle to slightly move causing a spinal tap".The patient's blood pressure dropped so the patient was kept for observation until the bp returned to baseline.Fluids were administered to help the patients blood pressure return to baseline.The patient's blood pressure was back to baseline the same day before discharge.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.

• Common Device Name: DBD-INTERLAMINAR 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: 21756596
• Report Number: 1417592-2025-00159
• Device Sequence Number: 13302541
• Product Code: OFT
• UDI-Device Identifier: 10198459111761
• UDI-Public: 10198459111761
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 04/02/2025

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: PAIN2173
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 04/02/2025
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 69 KG