MAUDE Adverse Event Report: CARDINAL HEALTH SCALPEL CURITY DISPOSABLE NO. 15; SCALPEL, ONE-PIECE

Model Number	131615
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that the blade was detached.Additional information was received and stated that the broken blade was discovered when opened on the tray.There was no harm reported.
Additional Manufacturer Narrative
The lot number was provided, and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.The product was manufactured on 03-feb-2022.Two pictures were provided for the investigation purposes.Upon visual evaluation, the reported issue is confirmed.A gemba walk was performed at the manufacturing process.A possible root cause that could have caused the blade to not seal properly on the gray handle was due to part placement issue on the ultrasonic welder machine.The operator should place the gray handle in the fixture and make sure not to find embedded material, contamination, or malformations in the handle.As an action plan, the production personnel received an awareness notification of the condition reported.At this time, a corrective and preventive action is not deemed necessary.We will keep monitoring the process for any adverse trends that require immediate attention.This complaint will be used for qa tracking and trending purposes.

• Brand Name: SCALPEL CURITY DISPOSABLE NO. 15
• Common Device Name: SCALPEL, ONE-PIECE
• Manufacturer (Section D): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 14105123
• Report Number: 9612030-2022-03218
• Device Sequence Number: 6284863
• Product Code: GDX
• UDI-Device Identifier: 10884527014491
• UDI-Public: 10884527014491
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2022

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
• Device Model Number: 131615
• Device Catalogue Number: 131615
• Device Lot Number: 2202511864
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/06/2022
• Supplement Date Received by Manufacturer: 04/06/2022
• Initial Report FDA Received Date: 04/13/2022
• Supplement Report FDA Received Date: 06/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown