MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; BLADE,STAINLESS-STEEL,10,STRL,DISPOSABLE

Catalog Number	CISION10SS
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	02/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the facility on 2/27, "there was significant resistance pushing the blade off the scalpel holder with needle drivers while cleaning up post-surgery.On one attempt, the blade (still attached to holder) rebounded after pushing with needle drivers and lacerated the lateral aspect of my right thumb".
Additional Manufacturer Narrative
According to the facility on 2/27, "there was significant resistance pushing the blade off the scalpel holder with needle drivers while cleaning up post-surgery.On one attempt, the blade (still attached to holder) rebounded after pushing with needle drivers and lacerated the lateral aspect of my right thumb".The facility stated that the laceration was wrapped with gauze prior to seeking out an urgent care facility.The laceration required 4 skin stitched.The laceration is healing well with some continued sensitivity and tightness at the site.It has been determined that the reported event caused or contributed to serious injury requiring medical intervention, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Common Device Name: BLADE,STAINLESS-STEEL,10,STRL,DISPOSABLE
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 21866096
• Report Number: 1417592-2025-00183
• Device Sequence Number: 4708978
• Product Code: GES
• UDI-Device Identifier: 10193489090123
• UDI-Public: 10193489090123
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: CISION10SS
• Device Lot Number: B00312L1
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2025
• Initial Report FDA Received Date: 04/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/02/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown