MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; MAJOR

Catalog Number	DYNJ901071K
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, "during pudenal nerve block, 25g hypo needle was inserted posteromedially to the ischial tuberosity.Upon aspiration, the needle was noted to be broken off at the connection with the plastic portion of the needle.Attempts to retrieve needle unsuccessful." no additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.No additional information is available.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.
Event or Problem Description
According to the customer, "during pudenal nerve block, 25g hypo needle was inserted posteromedially to the ischial tuberosity.Upon aspiration, the needle was noted to be broken off at the connection with the plastic portion of the needle.Attempts to retrieve needle unsuccessful.".
Additional Manufacturer Narrative
Update to h6: investigation findings.Update to h6: investigation conclusions.

• Common Device Name: MAJOR
• 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: 21885089
• Report Number: 1423395-2025-00035
• Device Sequence Number: 11645383
• Product Code: FDE
• UDI-Device Identifier: 10195327504298
• UDI-Public: 10195327504298
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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,Followup
• Report Date (Section B): 09/04/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJ901071K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2025
• Supplement Date Received by Manufacturer: 04/23/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 09/04/2025
• 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 Sex: Unknown