MAUDE Adverse Event Report: CARDINAL HEALTH 7318 SPG VISTEC 8 X 4 STR 10 S; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number	7318
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
Customer reports: raytex sponge breaks down into small pieces.
Additional Manufacturer Narrative
The device history record (dhr) and the 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.Based on the samples and the photographs, the complaint was confirmed.The selvage edges of the gauze are protruding out of the folded sections causing the loose threads.The selvage edges should be within the folds of the gauze to prevent loose threads.This could have been a placement error when the gauze was cut and folded.This were no issue identified as part of the in-process inspections; therefore, this could have been an isolated incident where a misfold cause the selvage edge to be protruding outside the folds.As this is considered an isolated event a formal corrective/preventative action is not applicable however, trending and monitoring will continue for this product issue.
Additional Manufacturer Narrative
The device history record was reviewed and there were no issues identified for lint or loose threads.There were no non-conformances related to this inspection criteria.The lot passed all the required in-process verification activities based on the acceptance quality level (aql) sample size.Based on the samples and the photographs, the complaint for breaking into small pieces was confirmed.The selvage edges of the gauze are protruding out of the folded sections causing the loose threads.The selvage edges should be within the folds of the gauze to prevent loose threads.This could have been a placement error when the gauze was cut and folded.This were no issue identified as part of the in-process inspections therefore this could have been an isolated incident where a misfold cause the selvage edge to be protruding outside the folds.As this is considered an isolated incident whereas a misfold caused the selvage edge to be protruding outside the folds a formal corrective/preventative action will not be initiated at this time.Trending and monitoring for the reported condition will continue.

• Brand Name: 7318 SPG VISTEC 8 X 4 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: 17685982
• Report Number: 1018120-2023-00486
• Device Sequence Number: 14098915
• Product Code: GDY
• UDI-Device Identifier: 00884527017006
• UDI-Public: 00884527017006
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/02/2024

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: 7318
• Device Catalogue Number: 7318
• Device Lot Number: 23C060962
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2023
• Supplement Date Received by Manufacturer: 08/30/2023; 08/30/2023
• Initial Report FDA Received Date: 09/05/2023
• Supplement Report FDA Received Date: 01/16/2024; 02/02/2024
• 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