MAUDE Adverse Event Report: CARDINAL HEALTH SPNG,GAUZE,4 IN X 4 IN,16 PLY,; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number	7148
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that only 9 gauze 4 x 4 xr sponges were found in the total hip pack.There was no harm reported.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that only 9 gauzes 4 x 4 xr sponges were found in the total hip pack.There was no harm reported.Additional information was received from the customer and stated that the defective product only had 9 individual pieces of gauze in the stack when it should have been 10.Per customer, 1 stack is equal to 1 defective product.
Additional Manufacturer Narrative
Section b5 has been updated to include additional information.
Additional Manufacturer Narrative
The lot number was provided, and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.No miscounted bundles were identified as part of the in-process inspection.A sample was received for the analysis.Based on the information available to us, we were able to confirm the event, and determined that the miscounted bundle could have been an isolated instance due to an error in the counter.The machine parameters are checked each shift, and the 10-count scale is subjected to scale challenges every day.If there was a systemic issue with the counting process it would have been identified and investigated.At this time, a corrective and preventive action is not deemed necessary.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.

• Brand Name: SPNG,GAUZE,4 IN X 4 IN,16 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: 17584746
• Report Number: 1018120-2023-00485
• Device Sequence Number: 4802162
• Product Code: GDY
• UDI-Device Identifier: 10884527016969
• UDI-Public: 10884527016969
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Followup
• Report Date (Section B): 12/19/2023

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: 7148
• Device Catalogue Number: 7148
• Device Lot Number: 23D054362
• 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: 08/16/2023
• Supplement Date Received by Manufacturer: 08/16/2023; 08/16/2023
• Initial Report FDA Received Date: 08/21/2023
• Supplement Report FDA Received Date: 08/30/2023; 12/19/2023
• 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