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

Model Number 50-11068

Device Problems Loss of or Failure to Bond (1068); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/04/2021

Event Type  malfunction  

Manufacturer Narrative

Representative samples were received for evaluation.A supplier corrective action request (scar) was issued to the sponge stick supplier (b)(4) inc.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 Description

The sponge on the stick from the kit came off when inside a patient.They have to remove it from the patient.

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
• Type of Device: 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: 12698577
• MDR Text Key: 281273111
• Report Number: 3005011024-2021-00012
• Device Sequence Number: 1
• Product Code: KDD
• UDI-Device Identifier: 00749756150149
• UDI-Public: 0749756150149
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2021
• 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
• Date Manufacturer Received: 10/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1