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

Model Number	4406
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	12/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that clipper blade was missing one of the teeth and blade.Verbatim: i am working with director of surgical services to obtain more details and see about getting the sample.Apparently, one of our clipper blades was missing one of the teeth on the blade.This led to patient harm per the cp manager.I have not seen the product or talked with a clinician who leads the department.I talked to her briefly on the morning of 10 december, she asked that i call her back later in the day, at 9:30am.I called back and left a message at that time.I will visit the account monday morning.
Additional Manufacturer Narrative
Pr (b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).A sample was received for evaluation.Visual examination of the clipper handle was completed and found this was caused by physical damage.It is assumed that the fixed blade was broken by dropping on the floor or hitting it against a hard surface.A production record review was completed for batch/lot 0521 and no non conformances were identified during the pre-shipping inspection of this lot during manufacturing.No further action is required.This failure will continue to be tracked and trended.

• Brand Name: SURGICAL CLIPPER BLADE (FOR GENERAL USE)
• Common Device Name: RAZOR, SURGICAL
• 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: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 13154062
• Report Number: 1423507-2021-00058
• Device Sequence Number: 4079096
• Product Code: LWK
• UDI-Device Identifier: 10885403473142
• UDI-Public: (01)10885403473142
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 12/16/2021

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 Model Number: 4406
• Device Catalogue Number: 4406
• Device Lot Number: 0521
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/09/2021
• Initial Report FDA Received Date: 01/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown