MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; SPINAL 25G QUINCKE

Catalog Number	DYNJRA1736
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the clear plastic wrap around the tray is loose and it shifts a lot within the package.The movement has been enough within the package that we have had broken ampules and uncapped needles.".
Additional Manufacturer Narrative
The customer reported that the clear plastic wrap around the tray is loose and it shifts a lot within the package, and the movement has been enough within the package that they have had broken ampules and uncapped needles.A sample was received for investigation; from the sample provided, there was a considerable amount of empty room in the breather pouch, two needles shifted around within the tray, and one of the needles was uncapped, and finished good production records and finished good pack build were reviewed.Based on the complaint details, sample evaluation, and investigation, the complaint is confirmed.The large pouch is causing additional shifting of the tray inside the pouch during transit, the root cause was determined to be pack design, and the division will monitor this issue for trending purposes.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: SPINAL 25G QUINCKE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: raveena sampathi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50869730
• Report Number: 1417592-2026-48943
• Device Sequence Number: 10690593
• Product Code: BSP
• UDI-Device Identifier: 10193489815191
• UDI-Public: 10193489815191
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 09/22/2026

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: DYNJRA1736
• Device Lot Number: 25DMF485
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/06/2026
• 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: 12/22/2025
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown