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 Code	Abrasion (1689)
Date of Event	01/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Surgery cancelled due to increased risk of infection.Anger of patient and surgeon, delayed treatment.Risk of complaints by the patient according to his own words, aggressive comments towards the team, threatening comments.Severity 3 - severe.Immediate action(s) call from surgeon expressing dissatisfaction file returned to patient as he wishes to be treated in another establishment.Snack given before departure, attempt at discussion impossible with (e patient given his virulence.Manager informed of situation.Transmissions of patient file on d-o (dxcare).
Additional Manufacturer Narrative
(b)(4) initial emdr submission.A follow up emdr will be submitted after sample evaluation has been completed.Jvil 26feb2024.
Additional Manufacturer Narrative
Sample was available for evaluation.Sample was delivered to the suppler manufacturer, panasonic, as was analyzed.Panasonic inspected the product and conducted appearance and sharpness tests.There were no abnormalities in appearance or structure.As for the sharpness, panasonic confirms that it can be cut without any problem and meet the sharpness standard.The most probable root cause was using the handle/blade with strong pressure to the skin.A production record review was completed for batch/lot 0623 and the pre-shipping inspection of this lot.Panasonic could not find any non-conformance of pre-shipping inspection data for 0623.Recommended corrective action from panasonic included: 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.It is also suggested more product training to the clinician in the hospital.This failure mode will continue to be tracked and trended.(b)(4).
Event or Problem Description
Dermabrasion during shaving of the surgical area following use of the clipper blade.Consequence: surgery cancelled due to increased risk of infection.Anger of patient and surgeon, delayed treatment.Risk of complaints by the patient according to his own words, aggressive comments towards the team, threatening comments.Severity 3 - severe.Immediate action(s): call from surgeon expressing dissatisfaction file returned to patient as he wishes to be treated in another establishment.Snack given before departure, attempt at discussion impossible with (e patient given his virulence.Manager informed of situation.Transmissions of patient file on d-o (dxcare).

• 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: 18778361
• Report Number: 1423507-2024-10003
• Device Sequence Number: 18185146
• Product Code: LWK
• UDI-Device Identifier: 10885403473142
• UDI-Public: (01)10885403473142
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2024

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: 0623
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2024
• Supplement Date Received by Manufacturer: 04/10/2024
• Initial Report FDA Received Date: 02/26/2024
• Supplement Report FDA Received Date: 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2023
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown