MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. CMC AV FISTULA PACK; GENERAL SURGERY TRAY (KIT)

Model Number	89-10536
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Pack contained suction tubing that appeared to have a brownish substance on what looks like the outside of the tubing.The patient was not in the room.The offending item along with the entire pack was removed.A new pack was brought in and carefully inspected prior to bringing the patient in the room.
Additional Manufacturer Narrative
A user facility medwatch report (# (b)(4)) was received on 02/14/2022 reporting pack contained suction tubing that appeared to have a brownish substance on what looks like the outside of the tubing.The patient was not in the room.A supplier corrective action request (scar) was issued to the tubing supplier (b)(4).The sample has not been returned to deroyal for evaluation at this time.This investigation is ongoing at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.
Additional Manufacturer Narrative
The tubing was returned to deroyal for evaluation.A supplier corrective action request (scar) was issued to the tubing supplier conmed.Potential root cause: raw material (resin) with foreign matter from conmed's supplier.Cleaning routing not determined in the header, mesh and the die.The following corrective actions have taken place by conmed: requested an incoming inspection of the resin.Updated orders to include the cleaning routing process to include the period of time of the change frequency, this includes changes in the header, the meshes, the dies as applied.The burned resin will be removed before it accumulates in the die.Deroyal no longer receives this product from conmed.This investigation is complete at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.

• Brand Name: CMC AV FISTULA PACK
• Common Device Name: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1501 east central avenue; lafollette TN 37766
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1501 east central avenue; lafollette TN 37766
• Manufacturer Contact: melissa logsdon ; 200 debusk lane; powell, TN 37849 ; 8653626157
• MDR Report Key: 13578076
• Report Number: 3005011024-2022-00008
• Device Sequence Number: 5526678
• Product Code: LRO
• UDI-Device Identifier: 00749756364003
• UDI-Public: 0749756364003
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2022

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
• Device Model Number: 89-10536
• Device Catalogue Number: 89-10536
• Device Lot Number: 55674310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2022
• Supplement Date Received by Manufacturer: 02/14/2022
• Initial Report FDA Received Date: 02/22/2022
• Supplement Report FDA Received Date: 04/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown