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

Model Number	139093
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the blade breaks from the handle of the scalpel easily.The entire blade is detaching from the handle.There has been no report of patient involvement.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.The device was manufactured on november 08, 2021.Two hundred and eighty-five samples in their original packaging of the finished good 139090 lot 2130617664 were received at the manufacturing site for investigation.The samples were visually inspected and functionally tested and the reported condition was confirmed in thirty-five of the samples.A corrective and preventative action has been initiated to investigate and address the reported condition.This complaint will be used for tracking and trending purposes.

• Brand Name: SCALPEL CURITY DISPOSABLE NO. 15
• Common Device Name: SCALPEL, ONE-PIECE
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• 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: 15678757
• Report Number: 9612030-2022-03441
• Device Sequence Number: 7941134
• Product Code: GDX
• UDI-Device Identifier: 10884527014521
• UDI-Public: 10884527014521
• 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): 11/30/2022

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: 139093
• Device Catalogue Number: 139093
• Device Lot Number: 2130617664
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2022
• Supplement Date Received by Manufacturer: 10/24/2022
• Initial Report FDA Received Date: 10/27/2022
• Supplement Report FDA Received Date: 11/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown