MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. ABD VASCULAR PACK RF; GENERAL SURGERY TRAY (KIT)

Model Number	89-3930
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A complaint was received on (b)(6) 2022 reporting the rfid gauze pack had debris in it.The issue was found during set up of the procedure.The report indicated it delayed the case by 30 to 40 minutes due to having to breakdown and reset.There was no patient involvement.A picture of the debris and gauze was provided to deroyal for evaluation.A supplier notification letter (snl) was issued to the gauze supplier covidien to make them aware of the issue.Since there were no previous reported similar complaints for this raw material.No root cause was determined by covidien due to a supplier notification letter (snl) being issued.Potential root cause determined by deroyal: manufacturer oversight during the manufacturing / production process.The following corrective actions have taken place by deroyal: added additional guidance to the manufacturing routing instructions to enlighten awareness for the reported issue received for debris in the rfid gauze.Production records were reviewed, and no issues were found.An inventory check of the gauze was made by deroyal, a total of (b)(4) gauze rf 4 x 4 lot 22011at 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.
Event or Problem Description
The rfid gauze pack had debris in it.

• Brand Name: ABD VASCULAR PACK RF
• 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: 15216830
• Report Number: 3005011024-2022-00027
• Device Sequence Number: 17401924
• Product Code: LRO
• UDI-Device Identifier: 00749756571333
• UDI-Public: 00749756571333
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/12/2022

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: 89-3930
• Device Lot Number: 57005937
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/03/2022
• Initial Report FDA Received Date: 08/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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