MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. OUTPATIENT MAJOR; GENERAL SURGERY TRAY

Model Number	89-3865
Medical Device Problem Codes	Defective Device (2588); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: an internal complaint (call (b)(4)) was received for a convenience kit (finished good 89-3865, lot 50905406) containing a mayo stand cover that was open at both ends, allowing a nurse to contaminate themselves during set up for a procedure.The original sample was reported to not be available for return.An email has been sent to contact personnel to request if a picture of the reported failure was available.As of the date of this report, a picture has not been received.The work order for the reported lot was reviewed for possible discrepancies that may have contributed to the reported event.No discrepancies were identified.The bill of materials for the finished good kit was reviewed, and the affected raw material component was identified as part 5-5262, which is supplied to deroyal by o&m halyard health.The 2018-2020 supplier corrective action request (scar) and supplier notification letter logs were reviewed for similar complaints.Previous complaints for the reported failure were identified; therefore, a scar was issued to the supplier.The due date is (b)(6) 2020.As of the date of this report, a response has not been received.The investigation is ongoing at this time.This report will be updated when new and critical information becomes available.
Event or Problem Description
As the scrub was covering the mayo stand with the mayo stand cover from the convenience kit, it was noted that the end of the mayo stand cover was open instead of being sealed.Thus, the scrub inadvertently contaminated herself in the process of placing the mayo stand cover on the mayo stand.
Event or Problem Description
As the scrub was covering the mayo stand with the mayo stand cover from the convenience kit, it was noted that the end of the mayo stand cover was open instead of being sealed.Thus, the scrub inadvertently contaminated herself in the process of placing the mayo stand cover on the mayo stand.
Additional Manufacturer Narrative
Root cause: the kit component is supplied to deroyal by o&m halyard health.Therefore, a supplier corrective action request (scar) was issued to o&m halyard.In its response, the supplier stated potential causes of incorrect machine parameter settings and machine failure were identified.Corrective action: in its scar response, o&m halyard stated it would evaluate the feasibility of implementing an access limit to mayo cover parameters and provide training related to the set-up document.Investigation summary an internal complaint (call (b)(4)) was received for a convenience kit (finished good 89-3865, lot 50905406) containing a mayo stand cover that was open at both ends, allowing a nurse to contaminate themselves during set up for a procedure.The original sample was reported to not be available for return.An email has been sent to contact personnel to request if a picture of the reported failure was available.A response was received that the item was discarded.The work order for the reported lot was reviewed for possible discrepancies that may have contributed to the reported event.No discrepancies were identified.The bill of materials for the finished good kit was reviewed, and the affected raw material component was identified as part 5-5262, which is supplied to deroyal by o&m halyard health.The 2018-2020 supplier corrective action request (scar) and supplier notification letter logs were reviewed for similar complaints.Previous complaints for the reported failure were identified; therefore, a scar was issued to the supplier.The due date is (b)(6) 2020.A response was received (b)(6) 2020 and accepted by deroyal personnel.The investigation is complete at this time.This report will be updated if new and critical information becomes available.

• Brand Name: OUTPATIENT MAJOR
• Common Device Name: GENERAL SURGERY TRAY
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1501 east central avenue; lafollette, tn
• MDR Report Key: 9752881
• Report Number: 3005011024-2020-00001
• Device Sequence Number: 11545778
• Product Code: LRO
• UDI-Device Identifier: 00749756568043
• UDI-Public: 00749756568043
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K842648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2020

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
• Operator of Device: Health Professional
• Device Model Number: 89-3865
• Device Lot Number: 50905406
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 02/25/2020
• Supplement Report FDA Received Date: 04/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 87 YR