MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline Industries, Inc.; TRAY, 24G WHIT SPINAL W/PHARM

Model Number	DYNJRA9038
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility on 01/19/23 "the hub of the introducer needle came clean off of the needle upon gentle pressure to remove the hub after the spinal was placed".Per the facility "the free floating needle was then mostly in the patient and was quickly removed by grasping the 2mm that was still outside the patient".Per the facility the patient did not require additional medical intervention or incur a serious injury related to the event.No additional information is available at this time.The sample was returned for evaluation, however, a definitive root cause could not be determined 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.
Event or Problem Description
According to the facility on 01/19/23 "the hub of the introducer needle came clean off of the needle upon gentle pressure to remove the hub after the spinal was placed".

• Brand Name: Medline Industries, Inc.
• Common Device Name: TRAY, 24G WHIT SPINAL W/PHARM
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16382773
• Report Number: 1417592-2023-00055
• Device Sequence Number: 6081919
• Product Code: OJH
• UDI-Device Identifier: 10193489830477
• UDI-Public: 10193489830477
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 02/15/2023

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: DYNJRA9038
• Device Catalogue Number: DYNJRA9038
• Device Lot Number: 22GBI814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2023
• Initial Report FDA Received Date: 02/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 45 YR
• Patient Sex: Male
• Patient Weight: 91 KG