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	02/28/2025
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, the date of event is provided as an estimate based on the information provided.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.Note, the date of event is provided as an estimate based on the information provided.Addendum: this supplemental mdr is submitted to document the results of sample evaluation and investigation performed to analysis root cause.Inspected the product and conducted appearance and sharpness tests.There were no abnormalities in appearance or structure.As for the sharpness, we confirm that it can be cut without any problem and meet the sharpness standard.A device history record review found no non-conformances associated with this issue during production of this batch.It was supposed that the event was caused by using the handle/blade with strong pressure to the skin and has provided in-use recommendations.At the time of use, please do not strongly press the blade against the skin.Gently slide it on the skin surface and cut slowly.In addition, it is suggested more product training to the clinician in the hospital.Complaints are monitored and reviewed for emerging trends.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: 21800849
• Report Number: 1423507-2025-00011
• Device Sequence Number: 20920149
• 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): 08/22/2025

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?: No
• 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: 08/22/2025
• Initial Report FDA Received Date: 04/08/2025
• Supplement Report FDA Received Date: 08/28/2025
• 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