MAUDE Adverse Event Report: CAREFUSION, INC SURGICAL CLIPPER BLADE (FOR GENERAL USE)

Catalog Number	4406
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Sharp Edges (4013)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	09/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that patient had a small amount of bleeding in the surgical site.Note, the date of event is considered to be a best estimate as ((b)(6) 2025) based on the date of awareness.Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported that a very experienced cna clipped the patient and caused a small amount of bleeding in the surgical site.These razors/clippers were reported to be dangerous, time consuming, and ineffective.
Additional Manufacturer Narrative
It was reported that patient had a small amount of bleeding in the surgical site.Note, the date of event is considered to be a best estimate as (18-sep-2025) based on the date of awareness.Addendum: h11: this supplemental mdr is submitted to document the results of investigation performed to analysis root cause.No photos or samples were received for evaluation.A device history record could not be evaluated as the lot number is unknown.Based on the available information, a definitive root cause could not be established.No conclusion can be made as to the extent to which the blade may have caused or contributed to the patient's clinical course.If there is any possibility of damaging the skin, it is likely due to excessive pressure being applied.It was recommended that at the time of use, please do not strongly press the blade against the skin.Gently slide the clipper across the surface and cut slowly.Complaints are monitored and reviewed for emerging trends.Updated fields: b4, g3, g6, h2, h10, h11.Corrected field: h6.Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported that a very experienced cna clipped the patient and caused a small amount of bleeding in the surgical site.These razors/clippers were reported to be dangerous, time consuming, and ineffective.

• Brand Name: SURGICAL CLIPPER BLADE (FOR GENERAL USE)
• Common Device Name: SURGICAL CLIPPER BLADE (FOR GENERAL USE)
• Manufacturer (Section D): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• Manufacturer Contact: andrew topoulos ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 23244625
• Report Number: 1423507-2025-00094
• Device Sequence Number: 10245574
• Product Code: LWK
• UDI-Device Identifier: 10885403473142
• UDI-Public: (01)10885403473142
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 4406
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2025
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 10/08/2025
• Supplement Report FDA Received Date: 02/23/2026
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown