MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline Industries, Inc.; COMBINED SPINAL AND EPIDURAL

Model Number	DYNJRA1268C
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	05/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer, on (b)(6)2023 the glass plunger was stuck on the wall of the glass syringe when using the spinal and epidural tray.
Additional Manufacturer Narrative
According to the customer, on (b)(6)2023 the glass plunger was stuck on the wall of the glass syringe when using the spinal and epidural tray.The customer reported they "re-attempted a l3-l4 with a plastic syringe" and it was "easy and atraumatic".The customer did not report any serious injury related to the reported incident.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Brand Name: Medline Industries, Inc.
• Common Device Name: COMBINED SPINAL AND EPIDURAL
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 17213501
• Report Number: 1417592-2023-00267
• Device Sequence Number: 20627269
• Product Code: OFT
• UDI-Device Identifier: 10193489905830
• UDI-Public: 10193489905830
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 06/27/2023

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 Model Number: DYNJRA1268C
• Device Catalogue Number: DYNJRA1268C
• Device Lot Number: 22LLA800
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2023
• Initial Report FDA Received Date: 06/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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