MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. SINGLE BASIN PACK; GENERAL SURGERY TRAY

Model Number 89-7647

Device Problems Break (1069); Material Fragmentation (1261); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/16/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: an internal complaint ((b)(4)) was received for a custom procedure pack (finished good 89-7647, lot 47965133) that contained a defective gauze component.The gauze had strands coming off of it, which posed a hazard to the surgical field.A sample was reported to be available.However, as of the date of this report, no sample has been returned to deroyal for evaluation.The complaint investigator reviewed the work order for possible discrepancies that may have contributed to the reported event.No discrepancies were identified.(b)(4).The supplier corrective action request (scar) and supplier notification letter logs were reviewed for similar complaints for the time period of 2016 to present.Similar incidents were identified and a scar was issued to the supplier.As of the date of this report, a response has not been received.(b)(4).Deroyal will continue to monitor post-market feedback and will recognize in the future if the issue reoccurs.

Event Description

A convenience kit contained gauze with strands coming off of it.The strands are an issue in the surgical field.

Manufacturer Narrative

Root cause: the raw material gauze is supplied to deroyal by cardinal health.Therefore, a supplier corrective action request (scar) was issued.The supplier responded july 25, 2019, and indicated it was unable to evaluate the root cause of the reported issue due to the absence of the actual sample.Therefore, the root cause is unknown.Corrective action: in its scar response, the supplier stated there are quality checks in the beginning, middle and end of lot production that require 80 bundles to be checked for loose threads and lint.These checks are recorded in the device history record.Investigation summary an internal complaint (call 45434) was received for a custom procedure pack (finished good 89-7647, lot 47965133) that contained a defective gauze component.The gauze had strands coming off of it, which posed a hazard to the surgical field.A sample was reported to be available, but no sample was ever returned.The customer did send the content label for the affected finished good and a strand of string that was reported as being from the gauze.The complaint investigator reviewed the work order for possible discrepancies that may have contributed to the reported event.No discrepancies were identified.The bill of materials for the finished good was reviewed and the affected component was identified as raw material 5-1175 (lot 18b170662), which is supplied to deroyal by cardinal health.The supplier corrective action request (scar) and supplier notification letter logs were reviewed for similar complaints for the time period of 2016 to present.Similar incidents were identified and a scar was issued to the supplier.A response was received july 25, 2019.The complaint investigator reviewed engineering change orders (eco) and discovered that after this finished good work order was completed august 30, 2018, an eco (48771) was completed to change raw material 5-1175 to raw material 5-19928 for future orders.Deroyal will continue to monitor post-market feedback and will recognize in the future if the issue reoccurs.The investigation is complete at this time.If new and critical information becomes available, this report will be updated.

Event Description

A convenience kit contained gauze with strands coming off of it.The strands are an issue in the surgical field.

• Brand Name: SINGLE BASIN PACK
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1501 east central avenue; lafollette TN 37766
• MDR Report Key: 8063716
• MDR Text Key: 129187484
• Report Number: 3005011024-2018-00007
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 50749756750283
• UDI-Public: 50749756750283
• Combination Product (y/n): N
• PMA/PMN Number: K842648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 08/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 89-7647
• Device Lot Number: 47965133
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1