MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. CHRONIC EAR PACK; GENERAL SURGERY TRAY (KIT)

Model Number	89-4393
Medical Device Problem Codes	No Apparent Adverse Event (3189); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The surgical team opened a chronic ear pack for a procedure.Inside were 10 4x4 x-ray detectable sponges wrapped in a paper band; but there was also a loose 4x4 x-ray detectable sponge loose in the basin.
Additional Manufacturer Narrative
A user facility medwatch report ((b)(4)) was received on 03/31/2022 reporting the surgical team opened a chronic ear pack for a procedure.Inside were 10 4x4 x-ray detectable sponges wrapped in a paper band; but there was also a loose 4x4 x-ray detectable sponge loose in the basin.The sample has not been returned for evaluation.Potential root cause: slip lapse assembly error, when placing the gauze into the tray.The assembler possibly pulled 1 each gauze from another stack.Corrective action: the employee responsible for this assembly error, no longer works with deroyal.This incident has been reviewed with the process manager.An inventory check was made by deroyal, a total of 125 gauze was inspected, and no discrepancies were identified during the inspection.This investigation is complete at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.

• Brand Name: CHRONIC EAR PACK
• Common Device Name: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1501 east central avenue; lafollette TN 37766
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1501 east central avenue; lafollette TN 37766
• Manufacturer Contact: melissa logsdon ; 200 debusk lane; powell, TN 37849 ; 8653626157
• MDR Report Key: 14101513
• Report Number: 3005011024-2022-00017
• Device Sequence Number: 4776535
• Product Code: LRO
• UDI-Device Identifier: 00749756585750
• UDI-Public: 00749756585750
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K842648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/13/2022

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: 89-4393
• Device Lot Number: 54854757
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 04/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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