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

Catalog Number	PAIN0763
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, during a "single shot spinal epidural the needle broke off under a patient's skin".The customer reported that after the reported incident occurred a "general surgeon needed to make an incision and remove the item".The customer reported the procedure completed and the patient was able to be discharged after the procedure.The customer reported there was no serious injury or follow-up care needed related to the reported incident.No additional information is available at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.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 customer, during a "single shot spinal epidural the needle broke off under a patient's skin".

• Common Device Name: SINGLE SHOT EPIDURAL TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes dr; northfield, IL 60093-2753
• MDR Report Key: 19448186
• Report Number: 1417592-2024-00631
• Device Sequence Number: 8747683
• Product Code: OGE
• UDI-Device Identifier: 40888277565198
• UDI-Public: 40888277565198
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 06/03/2024

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: PAIN0763
• Device Lot Number: 23KLA925
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2024
• Initial Report FDA Received Date: 06/03/2024
• 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: Male
• Patient Weight: 88 KG