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

Model Number 7318

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/30/2023

Event Type  malfunction  

Event Description

Customer reports: the raytex sponge breaks down into small pieces.

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

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.

Manufacturer Narrative

Customer photos were provided and evaluated as part of the completed investigation.

• Brand Name: 7318 SPG VISTEC 8 X 4 STR 10 S
• Type of Device: 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: 17686110
• MDR Text Key: 322674043
• Report Number: 1018120-2023-00487
• Device Sequence Number: 1
• Product Code: GDY
• UDI-Device Identifier: 00884527017006
• UDI-Public: 00884527017006
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2023
• 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: 23B022762
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1