MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; MYRINGOTOMY PACK CHW-LF

Catalog Number	DYNJ51438B
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "when i tried taking the blade off the handle, i couldn't loosen it from the handle.When i tried, the blade broke off the handle and a piece was stuck inside the beaver handle.".
Additional Manufacturer Narrative
It was reported that "while setting up for case, customer loaded the myringotomy blade on the beaver handle.When customer tried taking the blade off the handle, customer couldn't loosen it from the handle.When customer tried, the blade broke off the handle and a piece was stuck inside the beaver handle.Customer grabbed a large needle holder and tried to unscrew the handle with the needle holder.Customer was unsuccessful so had to grab a plier to hold the handle in place and used the needle holder to rotate the handle which loosened the handle and freed the piece of myringotomy blade that was stuck.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: MYRINGOTOMY PACK CHW-LF
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: juan mota ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50213476
• Report Number: 1417592-2026-15577
• Device Sequence Number: 6111282
• Product Code: OGR
• UDI-Device Identifier: 10198459022418
• UDI-Public: 10198459022418
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 08/11/2026

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: DYNJ51438B
• Device Lot Number: E502AIZ
• Was Device Available for Evaluation?: No
• 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: 03/07/2025
• Initial Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (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