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

Model Number	89-10552
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Opened up a cmc extremity pack.When we were unpacking the pack, we found a hair in the weave of the bottom sheet.Everything was taken down and new pack was done.The patient was not involved.
Additional Manufacturer Narrative
A user facility medwatch report ((b)(4)) was received on 11/2/2022 reporting an opened up a cmc extremity pack.When we were unpacking the pack, we found a hair in the weave of the bottom sheet.Everything was taken down and new pack was done.The patient was not involved.A supplier corrective action request (scar) was sent to the supplier o & m halyard health.The sample was returned to deroyal for evaluation on 11/7/2022.Deroyal reviewed product specifications and the work order for the specified product.An inventory check of 125 products were examined and were deemed to be acceptable.Deroyal also reviewed the failure modes and effects analysis and determined that it was not in need of an update.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 drape was returned to deroyal on 11/7/2022 for evaluation.A supplier corrective action request (scar) was issued to the drape supplier o&m halyard medical.Root cause: was established as a dirty area and not following good manufacturing practices.Issue was found during use, as part of the good manufacturing practices all personnel must use cloth-like hats and antistatic gowns.In addition to this, cutting personnel wear gloves to avoid damage on product.The following corrective and preventive actions have taken place by o&m halyard medical: internally (b)(4) was created to address this kind of issues.The taken actions were to create an audit commission to monitor the controlled access rules and retraining in the ja-07297 to all personnel.To prevent this from potentially happening in the future, o&m halyard medical notified the complaint and personnel were also notified of the issue.Production records were reviewed and no issues were found.An inventory check of the drapes was made by deroyal.A total of (b)(4) of the 5-1918 drapes were 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.
Additional Manufacturer Narrative
The drape was returned to deroyal on 11/7/2022 for evaluation.A supplier corrective action request (scar) was issued to the drape supplier o&m halyard medical.Root cause: was established as a dirty area and not following good manufacturing practices.Issue was found during use, as part of the good manufacturing practices all personnel must use cloth-like hats and antistatic gowns.In addition to this, cutting personnel wear gloves to avoid damage on product.The following corrective and preventive actions have taken place by o&m halyard medical: internally qnc-no3-22-00120 was created to address this kind of issues.The taken actions were to create an audit commission to monitor the controlled access rules and retraining in the ja-07297 to all personnel.To prevent this from potentially happening in the future, o&m halyard medical notified the complaint and personnel were also notified of the issue.Production records were reviewed and no issues were found.An inventory check of the drapes was made by deroyal.A total of 125 of the 5-1918 drapes were 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: CMC EXTREMITY 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: reagan newman ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 19928477
• Report Number: 3005011024-2022-00033
• Device Sequence Number: 2847402
• Product Code: LRO
• UDI-Device Identifier: 00749756363549
• UDI-Public: 00749756363549
• 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,Followup
• Report Date (Section B): 08/26/2024

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: 89-10552
• Device Lot Number: 57751905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/02/2022
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 08/07/2024; 08/26/2024
• 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