MAUDE Adverse Event Report: CARDINAL HEALTH 7317 SPG VISTEC 4X4 STR 10'S; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number	7317
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 that they opened a box of raytec sponges and there were only 9 in the box.Per additional information received on 14jun2022, the customer clarified that the individual package was missing one gauze out of 10 gauze.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Prior to release, the lot must be deemed acceptable by meeting the aql inspection criteria that are based on a valid sampling plan.Quality inspectors perform a statistical sample inspection, both functional and visual.Samples were not received for the investigation.Because a sample was not returned, we were unable to perform a follow up investigation to confirm the reported condition and determine the root cause.If samples are received at a later date, the complaint will be reopened, and the investigation will be updated accordingly.Corrective actions have already been implemented to address the reported condition.No further actions are required at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for tracking and trending purposes.

• Brand Name: 7317 SPG VISTEC 4X4 STR 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: 14732074
• Report Number: 1018120-2022-00467
• Device Sequence Number: 2214950
• Product Code: GDY
• UDI-Device Identifier: 10884527016990
• UDI-Public: 10884527016990
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2022

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: 7317
• Device Catalogue Number: 7317
• Device Lot Number: 22B026162
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/02/2022
• Supplement Date Received by Manufacturer: 05/02/2022
• Initial Report FDA Received Date: 06/17/2022
• Supplement Report FDA Received Date: 07/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown