MAUDE Adverse Event Report: CARDINAL HEALTH 7462 VISTEC SPG 8X4 12P T-10 S; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number	7462
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the item only contained 9 pieces of gauze.There was no harm reported.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The lot number 200064862 provided by the customer is invalid.Based on the reported item code, the lot number could be 20d064862.A review of the device history record (dhr) for lot number 20d064862 was performed.The manufacturing records were reviewed, and no related event occurred during the overall process for this lot.The investigation demonstrated that no related issue was recorded throughout all our manufacturing and control processes.Each lot is released based on an aql inspection.As per the final quality inspection report of this lot, all specification criteria were conforming.The product was in conformance to our specifications and was released for distribution meeting all established quality assurance acceptance levels.Based on the available information, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the issue and root cause analysis.However, as part of continuous improvements, a corrective and preventative action (capa) was opened to address the issue of product package miscounts for the similar product line.All the corrective actions defined during the capa process has been implemented.No internal non-conformance (nc) related to miscounts has been opened for this product code.We will keep monitoring the process for any adverse trends that require immediate attention.This complaint will be used for qa tracking and trending purposes.Section d4 (lot number): the lot number was originally reported as 200064862 and should be 20d064862.

• Brand Name: 7462 VISTEC SPG 8X4 12P T-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: 15543769
• Report Number: 1018120-2022-00469
• Device Sequence Number: 12387696
• Product Code: GDY
• UDI-Device Identifier: 10884527017065
• UDI-Public: 10884527017065
• 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): 11/16/2022

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: 7462
• Device Catalogue Number: 7462
• Device Lot Number: 20D064862
• 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: 10/03/2022
• Supplement Date Received by Manufacturer: 10/03/2022
• Initial Report FDA Received Date: 10/05/2022
• Supplement Report FDA Received Date: 11/16/2022
• 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