MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; DBD-TRAY, SPINAL PENCIL POINT 25G

Catalog Number	DYNJRA2475
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, in september 2025, the "25g needle broke off at the hub" within the "subcutaneous tissue" and was "unable to be visualized or palpated." the customer said a ct scan of the lumbar spine "showed the retained needle fragment in the subcutaneous tissue at l1-2 level" which was "retrieved under ir [interventional radiology] guidance." no additional information is available at this time.It has been determined that the reported event caused or contributed to a 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, in september 2025, the "25g needle broke off at the hub" within the "subcutaneous tissue" and was "unable to be visualized or palpated." the customer said a ct scan of the lumbar spine "showed the retained needle fragment in the subcutaneous tissue at l1-2 level" which was "retrieved under ir [interventional radiology] guidance.".

• Brand Name: MEDLINE
• Common Device Name: DBD-TRAY, SPINAL PENCIL POINT 25G
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: jessica walter ; three lakes drive; northfield, IL 60093
• MDR Report Key: 23811737
• Report Number: 1417592-2025-00715
• Device Sequence Number: 20754665
• Product Code: OFT
• UDI-Device Identifier: 10198459081385
• UDI-Public: 10198459081385
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• 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): 12/15/2025

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 Expiration Date: 01/31/2026
• Device Catalogue Number: DYNJRA2475
• Device Lot Number: 25BBJ518
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2025
• 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 Age: 37 YR
• Patient Sex: Female
• Patient Weight: 134 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White