MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. CORONARY BYPASS PACK PGYBK; GENERAL SURGERY TRAY (KIT)

Model Number	89-10544
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Hair found in laps.
Additional Manufacturer Narrative
A complaint was received on 05/28/2024 reporting hair found in laps.A supplier corrective action request (scar) was issued to the lap sponge supplier gd medical.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
A complaint was received on 05/28/2024 reporting hair found in laps.The sample was not returned to deroyal.A supplier corrective action request (scar) was issued to the lap sponge supplier (b)(4).Root cause was determined by the supplier (b)(4) that an operator did not properly follow the gowning procedure.The following corrective and preventive actions have been taken by (b)(4): workshop supervisors have been informed of the incident.The workshop supervisors reviewed the gowning procedure with the operators during in-process and finished product inspections.Quality assurance will check for hair during the manufacturing process.Workshop supervisors will review the gowning procedure with each operator at the start of each shift and ensure that workers are properly gowned throughout the entire shift.The quality team will closely monitor for any duplication or recurrence of the issue.Production records were reviewed, and no issues were found.An inventory check of the lab sponges was made by deroyal, a total of (b)(4) of the 5-1918 was inspected, and no discrepancies were identified during the inspection.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: CORONARY BYPASS PACK PGYBK
• 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: 19607664
• Report Number: 3005011024-2024-00010
• Device Sequence Number: 8121049
• Product Code: LRO
• UDI-Device Identifier: 00749756366342
• UDI-Public: 00749756366342
• 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): 07/11/2024

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: 89-10544
• Device Lot Number: 59892031
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/28/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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