MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; HAND PACK

Catalog Number	DYNJ86576
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
According to the facility on (b)(6) 2026, "when trying to the use #15 blade, during the surgery, the blade was so dull that it was barely cutting the skin.
Additional Manufacturer Narrative
According to the facility on (b)(6) 2026, "when trying to the use #15 blade, during the surgery, the blade was so dull that it was barely cutting the skin.The surgeon was not comfortable pushing any harder to make the cut.The facility used a different #15 blade from an extra box we stocked at the center" the facility stated the individual is "fine".No medical intervention, serious injury, or follow-up care has been reported.At this time, no information has been received to indicate that recurrence of the complaint-specific sequence of events detailed by the customer contact may likely cause or contribute to a death or serious injury.No adverse event report will be filed at this time.If additional relevant information becomes available this investigation will be re-opened and re-evaluated.

• Brand Name: MEDLINE
• Common Device Name: HAND PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: lauren glaeser ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 24758159
• Report Number: 1423395-2026-00064
• Device Sequence Number: 21161862
• Product Code: OJH
• UDI-Device Identifier: 10195327652395
• UDI-Public: 10195327652395
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJ86576
• Device Lot Number: 25LBS749
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 04/01/2026
• Supplement Report FDA Received Date: 05/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/26/2025
• 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
• Patient Sex: Unknown