MAUDE Adverse Event Report: CARDINAL HEALTH 7463 VISTEC SPG 8X4 16P 10'S; TAPE AND BANDAGE, ADHESIVE

Model Number	7463
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.  if additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
Customer reports: there were only nine instead of ten raytecs in the pack.
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: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): CARDINAL HEALTH; 1430 marvin griffin road, po b; augusta GA 30906
• MDR Report Key: 12554695
• Report Number: 1018120-2021-00455
• Device Sequence Number: 1296584
• Product Code: KGX
• UDI-Device Identifier: 10884527022540
• UDI-Public: 10884527022540
• 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: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2021

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: No Information
• Device Model Number: 7463
• Device Catalogue Number: 7463
• Initial Date Received by Manufacturer: 09/27/2021
• Supplement Date Received by Manufacturer: 09/27/2021
• Initial Report FDA Received Date: 09/30/2021
• Supplement Report FDA Received Date: 11/02/2021
• Patient Sequence Number: 1