MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; PAIN TRAY B THOMPSON

Catalog Number	DYNJRA2433
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that needle (component # (b)(4)) is not sharp enough and is a good bit duller than the previous needle (component # (b)(4)).
Additional Manufacturer Narrative
The account reported finding dull needle; according to the facility, during a pain management injection, the needle was observed to be more dull than expected, the needle was discarded and replaced, and no re-stick was required.A photo was received for investigation, and the customer provided a photo showing the provider holding two needles up; the only component of the needles that are visible are the needle hubs.The packs production record and bill of materials were reviewed, and no discrepancies were noted that would lead to the reported issue.Based on the complaint details and investigation, the complaint is not confirmed; the investigation was limited without receipt of the physical sample, and sample required to determine cause.There were no reports of death, serious injury, medical intervention, or follow up care.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 is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: PAIN TRAY B THOMPSON
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: sullivan bluhm ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50927325
• Report Number: 1417592-2026-52808
• Device Sequence Number: 10735216
• Product Code: OFT
• UDI-Device Identifier: 10198459036248
• UDI-Public: 10198459036248
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: DYNJRA2433
• Device Lot Number: 25JBS009
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 09/29/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown