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

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	03/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No samples or photos were available for evaluation.As a result, bd was unable to verify the reported issue or determine a definitive root cause.If samples, photos or additional information become available, bd will re-open and investigate accordingly.A production record review was completed for batch/lot 1021 and no non conformances were identified during manufacturing of this lot.No further action is required.This failure will continue to be tracked and trended.
Event or Problem Description
It was reported sharp.Email verbatim: multiple clipper injuries to patients in the pre-op dept.Of hospital.No changes in staff, the same nurses have been clipping for 4 and more years.Lot number 1021 resulted in a handful of nicks, cuts, and abrasions on patients.

• Brand Name: SURGICAL CLIPPER BLADE (GENERAL USE)
• Common Device Name: SURGICAL CLIPPER BLADE (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: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 13726061
• Report Number: 1423507-2022-00006
• Device Sequence Number: 12275738
• Product Code: LWK
• UDI-Device Identifier: 10885403473142
• UDI-Public: (01)10885403473142
• Combination Product (Y/N): Y
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/09/2022

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 Expiration Date: 10/01/2026
• Device Model Number: 4406
• Device Catalogue Number: 4406
• Device Lot Number: 1021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2022
• Initial Report FDA Received Date: 03/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown