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

Model Number	4406
Medical Device Problem Codes	Labelling, Instructions for Use or Training Problem (1318); Inaccurate Information (4051)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pr (b)(4) initial mdr.A follow up will be submitted if additional information becomes available.(b)(4).
Event or Problem Description
False expiration date.The use-by date of december 31, 2030 on the delivery note does not match the use-by date on the clipper blades (blade item no.4406) october 1, 2024.
Event or Problem Description
False expiration date.
Additional Manufacturer Narrative
A photo of the packing slip was provided to our quality team for evaluation.The correct expiration date is the one located on the product and not on the packing slip.The reasoning for the incorrect expiration date on the packing slip was due to a wrong expiration date being entered into the lots system when the product was received from panasonic.This is due to manual shipment preparation, without having the expiry date from the supplier.The correct expiration date has been updated in the lots system.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.

• Brand Name: SURGICAL CLIPPER BLADE (FOR GENERAL USE)
• Common Device Name: SURGICAL CLIPPER BLADE
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• MDR Report Key: 11335114
• Report Number: 1423507-2021-00004
• Device Sequence Number: 19038379
• Product Code: LWK
• UDI-Device Identifier: 10885403473142
• UDI-Public: (01)10885403473142
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2021

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: 10/30/2024
• Device Model Number: 4406
• Device Catalogue Number: 4406
• Device Lot Number: 1019
• Initial Date Received by Manufacturer: 01/18/2021
• Supplement Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 02/16/2021
• Supplement Report FDA Received Date: 07/01/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other