MAUDE Adverse Event Report: CARDINAL HEALTH 4334 VISTEC SPG 4X3.5 32 PLY; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number	4334
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that there was one bundled gauze that had 11 each banded together instead of 10 each.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record (dhr) was reviewed showing the lot met all the requirements and was released.No picture or physical sample was provided for investigation.No root cause or corrective action could be determined.This complaint will be used for tracking and trending purposes.

• Brand Name: 4334 VISTEC SPG 4X3.5 32 PLY
• 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: 16572719
• Report Number: 1018120-2023-00481
• Device Sequence Number: 7179946
• Product Code: GDY
• UDI-Device Identifier: 10884527016686
• UDI-Public: 10884527016686
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 04/10/2023

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: 4334
• Device Catalogue Number: 4334
• Device Lot Number: 22F026862
• 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: 02/27/2023
• Supplement Date Received by Manufacturer: 02/27/2023
• Initial Report FDA Received Date: 03/20/2023
• Supplement Report FDA Received Date: 04/10/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown