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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. OUTPATIENT MAJOR; GENERAL SURGERY TRAY
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DEROYAL INDUSTRIES, INC. OUTPATIENT MAJOR; GENERAL SURGERY TRAY Back to Search Results
Model Number 89-3865
Device Problems Defective Device (2588); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/27/2020
Event Type  malfunction  
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 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 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.
 
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.
 
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Brand Name
OUTPATIENT MAJOR
Type of Device
GENERAL SURGERY TRAY
Manufacturer (Section D)
DEROYAL INDUSTRIES, INC.
1501 east central avenue
lafollette, tn
MDR Report Key9752881
MDR Text Key207547035
Report Number3005011024-2020-00001
Device Sequence Number1
Product Code LRO
UDI-Device Identifier00749756568043
UDI-Public00749756568043
Combination Product (y/n)N
PMA/PMN Number
K842648
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Source Type user facility
Type of Report Initial,Followup
Report Date 04/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number89-3865
Device Lot Number50905406
Was Device Available for Evaluation? No
Date Manufacturer Received01/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age87 YR
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