MAUDE Adverse Event Report: GD MEDICAL COTTON BALL, MEDIUM 3/4", DOUBLE-STRUNG 5/PK 50 PKS/CS; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number	30-033
Medical Device Problem Code	Extra Components (4067)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A user facility reported, "sterile cotton ball package was opened and counted; package says 5 cotton balls, but contents equaled 10 when counted by surgical tech and verified by circulating rn.The event and package information was sent to [redacted], materials manager." deroyal industries, inc.Requested return of the product but it was unavailable to be returned.A supplier corrective action request (scar) will be issued to the supplier, gd medical.This investigation is not complete at this time.No further information is available at this time.We will provide follow up report when additional information is available.
Event or Problem Description
A user facility reported, "sterile cotton ball package was opened and counted; package says 5 cotton balls, but contents equaled 10 when counted by surgical tech and verified by circulating rn.The event and package information was sent to [redacted], materials manager.".
Additional Manufacturer Narrative
A user facility reported, "sterile cotton ball package was opened and counted; package says 5 cotton balls, but contents equaled 10 when counted by surgical tech and verified by circulating rn.The event and package information was sent to [redacted], materials manager." deroyal industries, inc.Requested return of the product but it was unavailable to be returned.The work order was reviewed for lot number 61925744.No inventory was available to be inspected at the distribution facility.It was originally stated that a supplier corrective action request (scar) will be issued to the supplier, gd medical, however, it was realized that this was not an issue due a supplier therefore no scar was issued.A complaint to sales ratio was conducted from (b)(6) 2023 to (b)(6) 2025 and found to be 0.005%.Root cause: it was found that the employee that processed the work order placed too many cotton balls in the package.Corrective and preventive actions: the employees that processed this work order were re-trained to ensure proper understanding.Deroyal will continue to monitor for trends around this item and issue.This investigation is complete at this time.No further information is available at this time.We will provide follow up report if additional information is available.

• Brand Name: COTTON BALL, MEDIUM 3/4", DOUBLE-STRUNG 5/PK 50 PKS/CS
• Common Device Name: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): GD MEDICAL; 1286 humbracht circle; bartlett IL 60103
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1703 highway 33 south; new tazewell TN 37825
• Manufacturer Contact: reagan facemire ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 22786249
• Report Number: 1060680-2025-00048
• Device Sequence Number: 15581417
• Product Code: GDY
• UDI-Device Identifier: 00749756027038
• UDI-Public: 00749756027038
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2025

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
• Operator of Device: Health Professional
• Device Model Number: 30-033
• Device Lot Number: 61925744
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown