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	01/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being filed due to a retrospective review of complaints.This complaint has been reopened for further investigation.A user facility medwatch report (# (b)(4)) was received reporting contaminated cmc extremity packs.The first extremity pack was found to have small black pieces on the medicine cup and the second pack appeared to have dried blood/red substance on the suction tubing.Samples were not returned for evaluation.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.
Event or Problem Description
Contaminated packs for case.The first extremity pack we found small black pieces on the medicine cup.This was before the patient entered the room.The pack was broken down and the entire setup was reset.For the same case, the patient was asleep and positioned.The 2nd extremity pack was in use when the scrub tech noticed black pieces on medicine cup and what appeared to be dried blood/red substance on the suction tubing while handing the suction to the surgeon.The team leader was called into the room.It was decided to quickly remove contaminated setup and reset the case.Both packs were the (cmc extremity packs).
Additional Manufacturer Narrative
Potential root cause: it was determined, but not limited to, possible employee failure to identify debris, possible dress code violation, lack of lab coat cleanliness, cleaning process not followed or inadequate, exposed product in warehouse, natural occurring static, equipment has loose particulate, inadequate customer satisfaction follow-up, possible inadequate controls identified, possible inadequate assembly methods/instructions, and debris contained in vendor supplied items.The following corrective actions have taken place: manufacturing personnel were retrained on the dress code procedure (corp.Prc.079), quality control specialist started conducting routine walk-throughs in raw material storage areas to identify any potentially exposed product, manufacturing personnel were instructed to wipe down production lines after every order, internal supplier personnel were confirmed to be trained on the cleaning and sanitation procedure, internal supplier performed quality assessment of its processes to confirm compliance and no issues were found, sub-assemblies were created to place all items potentially containing/attracting lint together prior to final assembly, and added additional guidance to the manufacturing instructions to indicate that these products have had reports of debris to increase scrutiny during the assembly process.The deroyal sales representative conducted an initial site visit on (b)(6) 2021 in regards to reported complaints of contamination (hair and debris) in procedure trays and collected various defective product samples.The samples were provided in bulk and were not able to be correlated to the corresponding reported quality events.The sales representative performed a follow-up visit on (b)(6) 2021, and the customer agreed to individually bag each separate complaint sample in the future.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
• MDR Report Key: 12258395
• Report Number: 3005011024-2021-00008
• Device Sequence Number: 5002163
• Product Code: LRO
• UDI-Device Identifier: 00749756363549
• UDI-Public: 00749756363549
• Combination Product (Y/N): Y
• 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): 09/08/2021

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: No Information
• Device Model Number: 89-10552
• Device Catalogue Number: 89-10552
• Device Lot Number: 53457565
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/15/2021
• Supplement Date Received by Manufacturer: 01/15/2021
• Initial Report FDA Received Date: 08/02/2021
• Supplement Report FDA Received Date: 09/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1