MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. OPEN HEART PACK; GENERAL SURGERY TRAY

Model Number 89-8572

Device Problems Contamination /Decontamination Problem (2895); Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/13/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: an internal complaint ((b)(4)) was received for an open heart tray (part 89-8572, lot 50207448) that contained a contaminated drape.A bug was found on the velcro of the drape after the patient had been draped for the procedure.The defective sample was not returned for evaluation.The work order was reviewed for possible discrepancies that may have contributed to the reported event.No such discrepancies were identified.Quality records relative to pest control were reviewed for the three months prior to this work order to confirm the manufacturing facility was following pest control procedure.The affected drape was identified as raw material 5-15402, which is supplied to deroyal by halyard.This material comes to deroyal in bulk with 8 folded drapes per cardboard box.Deroyal manufacturing personnel do not unfold these drapes at any time during the assembly process; therefore, a bug located on the velcro would not be noticeable to employees.The 2017-2019 supplier corrective action request (scar) and supplier notification letter logs were reviewed for similar issues.No previous reports were identified; however, due to the severity of the reported issue, a scar was sent to halyard.As of the date of this report, a response has not been received.The investigation is ongoing at this time.When new and critical information is received, this report will be updated.

Event Description

A bug was found in the velcro of a drape during an open heart procedure.The patient was already draped for the procedure when it was discovered.

Manufacturer Narrative

Root cause: the affected drape is supplied to deroyal by halyard.Therefore, a supplier corrective action request (scar) was issued to halyard.In its response, the supplier stated that with no sample or picture available, the position of the bug could not be confirmed and a root cause could not be identified.Corrective action: a corrective action has not been taken due to the root cause determination.Investigation summary an internal complaint (call 47898) was received for an open heart tray (part 89-8572, lot 50207448) that contained a contaminated drape.A bug was found on the velcro of the drape after the patient had been draped for the procedure.The defective sample was not returned for evaluation.The work order was reviewed for possible discrepancies that may have contributed to the reported event.No such discrepancies were identified.Quality records relative to pest control were reviewed for the three months prior to this work order to confirm the manufacturing facility was following pest control procedure.The affected drape was identified as raw material 5-15402, which is supplied to deroyal by halyard.This material comes to deroyal in bulk with 8 folded drapes per cardboard box.Deroyal manufacturing personnel do not unfold these drapes at any time during the assembly process; therefore, a bug located on the velcro would not be noticeable to employees.The 2017-2019 supplier corrective action request (scar) and supplier notification letter logs were reviewed for similar issues.No previous reports were identified; however, due to the severity of the reported issue, a scar was sent to halyard.A response was received october 14, 2019 and accepted by deroyal personnel.The investigation is complete at this time.If new and critical information is received, this report will be updated.

Event Description

A bug was found in the velcro of a drape during an open heart procedure.The patient was already draped for the procedure when it was discovered.

• Brand Name: OPEN HEART PACK
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1501 east central avenue; lafollette TN 37766
• MDR Report Key: 8977598
• MDR Text Key: 206991118
• Report Number: 3005011024-2019-00009
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00749756864169
• UDI-Public: 00749756864169
• 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: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 89-8572
• Device Lot Number: 50207448
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1