MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. ST PREP KIT DRY LATEX SAFE 20C; KIT, SURGICAL INSTRUMENT, DISPOSABLE

Model Number	50-11068
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Representative samples were received for evaluation.A supplier corrective action request (scar) was issued to the sponge stick supplier (b)(4).This investigation is ongoing 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 sponge on the stick from the kit came off when inside a patient.They have to remove it from the patient.
Additional Manufacturer Narrative
A supplier corrective action request (scar) was issued to the supplier welmed inc.Root cause: the supplier welmed inc.Has determined that their standard operating procedures did not specify the disposal method of the product during the machine commissioning period.The following corrective actions have taken place by the supplier welmed inc: quality assurance checked the equipment parameters of the on-site welding machine and found the equipment parameters were in compliance with the verification documents.Supplier conducted containment and tensile tests on the products in the inventory, no issues were found.The following preventive actions have taken place by the supplier welmed inc: added the disposal method of the product during the debugging period in the standard operating procedure.All products during the debugging period are discarded as scrap.The first 10 molds are scrapped after the debugging is qualified, and the 11th mold will be used for the first article inspection.The following corrective action have taken place by deroyal: the sponge stick was set to be evaluated during the incoming inspection process.Two separate lot numbers have been received and inspected with no issues found.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: ST PREP KIT DRY LATEX SAFE 20C
• Common Device Name: KIT, SURGICAL INSTRUMENT, DISPOSABLE
• 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: 12698579
• Report Number: 3005011024-2021-00014
• Device Sequence Number: 3706023
• Product Code: KDD
• UDI-Device Identifier: 00749756150149
• UDI-Public: 0749756150149
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2021

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: 50-11068
• Device Lot Number: 55231818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2021
• Supplement Date Received by Manufacturer: 10/05/2021
• Initial Report FDA Received Date: 10/26/2021
• Supplement Report FDA Received Date: 11/17/2021
• 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