MAUDE Adverse Event Report: CARDINAL HEALH DERMACEA X-RAY SPG 4X4 16 PLY; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number	441601
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that one pack of sponges contained 11 pieces instead of 10 and another contained 9 instead of 10.No injuries occurred.
Additional Manufacturer Narrative
The incident samples have been requested but to date have not been received for evaluation.If the samples are received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.
Additional Manufacturer Narrative
The device history records (dhr) were reviewed for all possible lot numbers provided and indicated that the product was released accomplishing all quality standards.There were no exceptions recorded that could lead to the issue reported.A physical sample was not received for the investigation.If samples are received at a later date, the complaint will be reopened, and the investigation will be updated accordingly.Retained samples were inspected and there were no miscounts found.The manufacturing process was also reviewed; the gauze sponges are banded every ten pieces.One piece of gauze sponge is indexed out for each ten-piece bundle during machine folding which is the first count that takes place.A worker then bands 10 sponges in a bundle and verifies the count for a second time.The 10 pieces of banded gauze sponges are then weighed at an automatic weighing system before packaging to confirm the quantity a third time.Only product with the correct quantity is then transferred to the next process stage.Sampling inspections are performed during both the production process and final product release process to ensure that the sponge quantities are correct.There were no abnormal findings during the entire investigation including the review of the manufacturing process, retained samples, and the dhrs.As a result, the root cause of this issue could not be determined, and corrective actions are not applicable at this time.The details of this complaint will be communicated to the relevant sectors for awareness.In addition, we will continue to track and trend this type of issue as part of our complaint review process.

• Brand Name: DERMACEA X-RAY SPG 4X4 16 PLY
• Common Device Name: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): CARDINAL HEALH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 13094399
• Report Number: 1282497-2021-10666
• Device Sequence Number: 17182741
• Product Code: GDY
• UDI-Device Identifier: 10884527021239
• UDI-Public: 10884527021239
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2022

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: 441601
• Device Catalogue Number: 441601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/23/2021
• Supplement Date Received by Manufacturer: 12/23/2021
• Initial Report FDA Received Date: 12/28/2021
• Supplement Report FDA Received Date: 02/02/2022
• 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