MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. LOWER EXTREMITY PACK; GENERAL SURGERY TRAY

Model Number	89-5320
Medical Device Problem Codes	Contamination (1120); Device Contamination with Body Fluid (2317); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: a user facility medwatch report (#(b)(4)) was received reporting that a gown packaged in a convenience kit (part 89-5320, lot 52509036) malfunctioned during use, allowing fluid to strike through the gown.The investigation is ongoing at this time.When new and critical information is received, this report will be updated.
Event or Problem Description
A surgical gown packaged in a convenience kit allowed strikethrough.The patient's bodily fluids were on the physician's arm and soaked through the scrub sleeve.The patient is (b)(6).
Additional Manufacturer Narrative
Root cause: the gown is supplied to deroyal by cardinal health.Therefore, a supplier corrective action request (scar) was issued to cardinal health.In its scar response, cardinal health stated that a root cause could not be determined without a sample.The device history record, manufacturing process, and raw material incoming inspection were reviewed and no discrepancies were identified that could have contributed to the reported event.Corrective action: in its scar response, cardinal health stated the complaint information was communicated to relevant personnel for their awareness.Investigation summary: a user facility medwatch report (#4100070000-2020-8068) was received reporting that a gown packaged in a convenience kit (part 89-5320, lot 52509036) malfunctioned during use, allowing fluid to strike through the gown.A sample was not available for return.Deroyal personnel contacted the initial reporter to request a picture of the reported failure.A picture was not made available.The work order for the reported finished good tray was reviewed for any discrepancies that may have contributed to the reported event.No discrepancies were identified.The bill of material (bom) was reviewed to identify the relevant raw material component.This material was identified as 718442, which is supplied to deroyal by cardinal health.A scar was issued to cardinal health.A response was received march 2, 2021 and accepted by deroyal personnel.There was inventory of the affected gown on hand in deroyal's warehouse.This inventory was reviewed for any signs of strike thru on the gowns.Nothing was found during this review.The investigation is complete at this time.If new and critical information becomes available, this report will be updated.
Event or Problem Description
A surgical gown packaged in a convenience kit allowed strike through.The patient's bodily fluids were on the physician's arm and soaked through the scrub sleeve.The patient is hepatitis c positive.

• Brand Name: LOWER EXTREMITY PACK
• Common Device Name: GENERAL SURGERY TRAY
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1501 east central avenue; lafollette TN 37766
• MDR Report Key: 10765548
• Report Number: 3005011024-2020-00006
• Device Sequence Number: 16942787
• Product Code: LRO
• UDI-Device Identifier: 00749756632836
• UDI-Public: 00749756632836
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K842648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2021

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: 89-5320
• Device Lot Number: 52509036
• Initial Date Received by Manufacturer: 10/01/2020
• Supplement Date Received by Manufacturer: 10/01/2020
• Initial Report FDA Received Date: 10/30/2020
• Supplement Report FDA Received Date: 03/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 33 YR