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 Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the vistec x-ray detectable sponges are out of the package noticeably fraying.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that the vistec x-ray detectable sponges are out of the package noticeably fraying.The reporter indicated that the sponges seem to be cut incorrectly.
Additional Manufacturer Narrative
Updated the event description in section b5 describe event or problem as the last sentence was inadvertently omitted on the initial report.Also, the initial reporter's zip code was corrected from 17402 to 17042 in section e1 initial reporter name and address.
Additional Manufacturer Narrative
A review of the device history report (dhr) was performed showing no related incidents.All dhrs are reviewed for accuracy prior to product release.There are implemented controls to prevent nonconforming product in the manufacturing process which ensures components and finished products meet all quality inspection standards.These controls include but are not limited to: material verification/certification processes, dimensional specifications, statistical samplings, periodic audits, process inspections, machine maintenance/operation and personnel training and certification.No samples or photos were returned for evaluation.If a sample is returned at a later date, the investigation will be reopened and updated accordingly.Based on the available information, the reported issue was not confirmed, and a root cause could not be determined.No corrective actions are being taken at this time.However, the production personnel visually inspect 100% of the product and a check for fraying is included in the inspection.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: 15280116
• Report Number: 1018120-2022-00468
• Device Sequence Number: 7054671
• Product Code: GDY
• UDI-Device Identifier: 10884527016990
• UDI-Public: 10884527016990
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/05/2022

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: 22C022262
• 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: 08/19/2022
• Supplement Date Received by Manufacturer: 08/19/2022; 08/19/2022
• Initial Report FDA Received Date: 08/23/2022
• Supplement Report FDA Received Date: 09/14/2022; 10/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown