MAUDE Adverse Event Report: CARDINAL HEALTH 7462 VISTEC SPG 8X4 12P T-10 S; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number	7462
Medical Device Problem Code	Component Missing (2306)
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 the item only contained 9 in the set of 10.Per additional information received, there was no medical intervention required.
Additional Manufacturer Narrative
A photo sample was received for the investigation.A device history record review could not be performed because the lot number received was not valid.Upon a visual evaluation of the photo sample, the reported issue was not confirmed.A corrective action is not applicable at this time.If a physical sample is received at a later date, this complaint will be reopened for further investigation.This complaint will be used for tracking and trending purposes.

• Brand Name: 7462 VISTEC SPG 8X4 12P T-10 S
• Common Device Name: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 1430 marvin griffin road, po b; augusta GA 30906
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 17353390
• Report Number: 1018120-2023-00484
• Device Sequence Number: 5467006
• Product Code: GDY
• UDI-Device Identifier: 10884527017065
• UDI-Public: 10884527017065
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2023

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: 7462
• Device Catalogue Number: 7462
• Device Lot Number: 1535747
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2023
• Supplement Date Received by Manufacturer: 06/23/2023
• Initial Report FDA Received Date: 07/19/2023
• Supplement Report FDA Received Date: 09/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown