MAUDE Adverse Event Report: CARDINAL HEALTH 7463 VISTEC SPG 8X4 16P 10'S; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number	7463
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The package has has 8 instead of 10 raytec gauze sponges.
Additional Manufacturer Narrative
The complaint sample was not received, and the lot number was reported as unknown, hence there is no lot# to refer to review the dhr and determine when that lot was manufactured.All device history records (dhrs) are reviewed by quality assurance prior to release.For sterilized products, the dhr and the sterilization documents undergo further review prior to release to the distribution center.Prior to a lot¿s release, the lots must be deemed acceptable, passing inspections that are based on a valid sampling plan.Inspectors routinely examine a statistical sample both physically and visually.When that lot was manufactured.A formal corrective / preventative action (capa) established potential root causes for a report of a miscount.The potential root causes were determined to be the banding and packaging including the accuracy and consistency of the scales used to weigh the sponges had not been verified; the procedure to set up the scales did not reflect the current process; for smaller sized product codes, extra movement is performed by rotating the sponges prior to banding; and there were no guidelines for the tightness of the band which could inadvertently create miscounts.

• Brand Name: 7463 VISTEC SPG 8X4 16P 10'S
• Common Device Name: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): CARDINAL HEALTH; 1430 marvin griffin road, po b; augusta GA 30906
• 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: 12640691
• Report Number: 1018120-2021-00456
• Device Sequence Number: 1140516
• Product Code: GDY
• UDI-Device Identifier: 10884527017089
• UDI-Public: 10884527017089
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2021

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
• Device Model Number: 7463
• Device Catalogue Number: 7463
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2021
• Supplement Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 10/15/2021
• Supplement Report FDA Received Date: 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown