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	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the product is shredding before use.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record (dhr) was reviewed, showing no manufacturing or inspection anomalies issued against this lot number.No physical sample was provided for evaluation.A photo was provided, and the reported condition was confirmed.Without a physical sample the exact root cause could not be determined.The production supervisor, manufacturing manager, and necessary production personnel have been made aware of the issue.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: 16194585
• Report Number: 1018120-2023-00474
• Device Sequence Number: 5794550
• Product Code: GDY
• UDI-Device Identifier: 10884527016990
• UDI-Public: 10884527016990
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2023

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: 7317
• Device Catalogue Number: 7317
• Device Lot Number: 22A011962
• 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: 01/17/2023
• Supplement Date Received by Manufacturer: 01/17/2023
• Initial Report FDA Received Date: 01/18/2023
• Supplement Report FDA Received Date: 01/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown