MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; BLADE,CARBON-STEEL,15,STRL,DISPOSABLE

Catalog Number	CISION15CS
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "in 2 separate cases today i had the scalpel blade i was using fracture during incision.".
Additional Manufacturer Narrative
The customer reported that in 2 separate cases the scalpel blade fractured during use for incision, and stated no adverse event occurred after the scalpel broke and no medical or surgical treatment was required.One box of brand-new items in their original packaging was received for investigation; visual and physical inspections were conducted, no visual abnormalities were observed, and during physical inspection the blade fractured and broke in half while handling and gently bending the item for closer evaluation.Based on the complaint details, sample evaluation, and investigation, the complaint has been confirmed.Physical inspection revealed that the item exhibited reduced mechanical integrity and broke easily; the root cause of this issue cannot be determined.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: BLADE,CARBON-STEEL,15,STRL,DISPOSABLE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: lauren glaeser ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50933787
• Report Number: 1417592-2026-53277
• Device Sequence Number: 18825031
• Product Code: GES
• UDI-Device Identifier: 10193489090185
• UDI-Public: 10193489090185
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• 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: CISION15CS
• Device Lot Number: B01503
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/04/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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