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

Catalog Number	4406
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Codes	Erythema (1840); Localized Skin Lesion (4542)
Date of Event	02/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the blade was extremely sharp, caused injury to patient's skin, skin was red and had lesion.
Additional Manufacturer Narrative
As reported, the blade was extremely sharp, caused injury to patient's skin, skin was red and had lesion.A supplemental mdr will be submitted after sample is received and evaluation has been completed.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.
Additional Manufacturer Narrative
As reported, the blade was extremely sharp, caused injury to patient's skin, skin was red and had lesion.A supplemental mdr will be submitted after sample is received and evaluation has been completed.Addendum this supplemental mdr is submitted to document the result of investigation performed to analysis root cause.Surgical clipper blades were returned for evaluation.Appearance testing was completed and no abnormalities in appearance or structure were identified.A sharpness test was also completed, and the blade cut without any problem which met the product sharpness standards.The most probable root cause of the minor injuries was using the handle/blade with strong pressure to the skin.A device history record review was completed for lot 0224, examined pre-shipping inspection of the lot and no non-conformances was found.Complaints are monitored and reviewed for emerging trends.Updated fields: b4, d9, g3, g6, h2, h6, h10.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
As reported, the blade was extremely sharp, caused injury to patient's skin, skin was red and had lesion.

• 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: 21800850
• Report Number: 1423507-2025-00010
• Device Sequence Number: 20920150
• Product Code: LWK
• UDI-Device Identifier: 10885403473142
• UDI-Public: (01)10885403473142(11)240418(17)290201(10)0224
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 4406
• Device Lot Number: 0224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2025
• Supplement Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 04/08/2025
• Supplement Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2024
• 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