MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; MINOR BASIC TRAY PK

Catalog Number	DYNJ46218C
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/18/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility, while injecting the patient, the needle broke off at the base and remained in the patient's skin.The facility reported that the needle was initially unable to be located and could not be removed for approximately ten minutes.Once the needle was located, it was removed from the patient's skin.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, while injecting the patient, the needle broke off at the base and remained in the patient's skin.The facility reported that the needle was initially unable to be located and could not be removed for approximately ten minutes.Once the needle was located, it was removed from the patient's skin.

• Brand Name: MEDLINE
• Common Device Name: MINOR BASIC TRAY PK
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes dr; northfield IL 60093
• Manufacturer Contact: gavin-ainsley nadong ; three lakes dr; northfield, IL 60093
• MDR Report Key: 24695147
• Report Number: 1423395-2026-00052
• Device Sequence Number: 10151260
• Product Code: LRO
• UDI-Device Identifier: 10193489854480
• UDI-Public: 10193489854480
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 03/25/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJ46218C
• Device Lot Number: 25KBL936
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/18/2025
• 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