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	04/05/2022
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 received a call from the operating room and the gauze is shredding when being used on the patient.
Additional Manufacturer Narrative
The device history record (dhr) was reviewed.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 by passing inspections that are based on a valid sampling plan.Inspectors routinely examine a statistical sample both physically and visually.The reported lot met all the defined acceptance requirements and was released.Inspection records show no failures.On evaluation of the sample, minor fraying could be seen.The reported condition was confirmed.The root cause was determined to be the set screws for the heat roller on the machine were loose.Corrective action performed was the manufacturing associates involved with the process to produce this product have been made aware of the issue and are to be alert to this kind of issue.Samples were sent to the production associates for further awareness and the quality impact to our customers.The set screws for the heat roller on the machine are being monitored for looseness.This complaint will be recorded 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; 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: 14197004
• Report Number: 1018120-2022-00464
• Device Sequence Number: 4446995
• Product Code: GDY
• UDI-Device Identifier: 10884527016990
• UDI-Public: 10884527016990
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2022

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: 21H032762
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/05/2022
• Supplement Date Received by Manufacturer: 04/05/2022
• Initial Report FDA Received Date: 04/25/2022
• Supplement Report FDA Received Date: 05/23/2022
• 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