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 Codes	Material Frayed (1262); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.Device evaluation comment - the customer stated that the device will not be returned for evaluation because it has been discarded.
Event or Problem Description
Multiple departments are reporting that the product is unraveling or fraying while in use.
Additional Manufacturer Narrative
The device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the reported condition as described by the customer.The dhr review shows that all acceptance criteria inspections were within acceptable limits during the production process.There were no samples received with this complaint therefore a product evaluation was not possible however a photograph was provided and confirmed the reported condition.Without a sample to evaluate, a definitive root cause and corrective action cannot be determined.

• 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: 16469802
• Report Number: 1018120-2023-00479
• Device Sequence Number: 7672025
• Product Code: GDY
• UDI-Device Identifier: 10884527016990
• UDI-Public: 10884527016990
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/23/2023

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: 22M061162
• 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: 03/01/2023
• Supplement Date Received by Manufacturer: 03/01/2023
• Initial Report FDA Received Date: 03/02/2023
• Supplement Report FDA Received Date: 03/23/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown