MAUDE Adverse Event Report: CAREFUSION 213, LLC 0113 SURGICAL CLIPPER BLADE (FOR GENERAL USE)

Model Number	4406
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	12/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).
Event or Problem Description
Material no.: 4406, batch no.: unknown.It was reported that blade nic'd patients severely.Verbatim: srg bd surgical clipper used with general purpose blade nic'd patients severly.
Additional Manufacturer Narrative
Neither lot nor sample was provided, the failure mode could not be confirmed.The manufacture of the product stated the following" 1.At the time of use, please do not strongly press the blade against the skin, please slide gently on the skin surface and cut.2.We suggest more product training to the clinician in the hospital.3.To sensitive area, it is recommended to use sensiclip (4403a)." bd will continue to track and trend for this failure mode.
Event or Problem Description
Material no.: 4406 batch no.: unknown.It was reported that blade nic'd patients severely.Verbatim: srg bd surgical clipper used with general purpose blade nic'd patients severly.

• Brand Name: SURGICAL CLIPPER BLADE (FOR GENERAL USE)
• Common Device Name: SURGICAL CLIPPER BLADE (FOR GENERAL USE)
• Manufacturer (Section D): CAREFUSION 213, LLC 0113; 1550 northwestern dr; el paso TX 79912
• 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: 13180319
• Report Number: 3004932373-2021-00548
• Device Sequence Number: 17492123
• Product Code: LWK
• UDI-Device Identifier: 10885403473142
• UDI-Public: (01)10885403473142
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Followup
• Report Date (Section B): 04/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 4406
• Device Catalogue Number: 4406
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2021
• Supplement Date Received by Manufacturer: 04/12/2022
• Initial Report FDA Received Date: 01/06/2022
• Supplement Report FDA Received Date: 04/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown