MAUDE Adverse Event Report: US MEDCO INC. OR TOWEL, BLUE, X-RAY DETECT., GEOMED, STERILE, 4/PK, 20PK/CS; FIBER, MEDICAL, ABSORBENT

Model Number	DT04-B-M
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Ordered (b)(4) case of item dt04-b-ma, received (b)(4)\, and need to return (b)(4) case because it is a safety hazard.The towels are not delinted and cannot be used in surgeries due to the lint in the towel.
Additional Manufacturer Narrative
A user facility reported on 2/23/2023 that, "sr (b)(6) advised that the va account has ordered (b)(4) case of item dt04-b-ma, received (b)(4), and need to return (b)(4) case because it is a safety hazard.The towels are not delinted and cannot be used in surgeries due to the lint in the towel".The device has not yet been returned to the manufacturer.A supplier corrective action request (scar) will be requested from us medco inc.This investigation is not complete at this time.No further information is available at this time.We will provide follow-up report once more information is available.
Additional Manufacturer Narrative
The device was requested multiple times, but never returned to deroyal industries for testing.Deroyal industries reviewed failure modes and effects analysis (fmea) and to see if there were any corrective actions and preventive actions (capas) for this item.No issues were found with either of these reviews.A supplier corrective action request (scar) was requested from us medco inc.Us medco inc.Responded to the request stating that because there was no lot number given or no sample returned, they could not do an investigation or give any further information.Therefore, because with no lot number, no sample returned, and no completed scar, the root cause of the issue was unable to be determined.Deroyal will continue to monitor for trends for this item and issue.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: OR TOWEL, BLUE, X-RAY DETECT., GEOMED, STERILE, 4/PK, 20PK/CS
• Common Device Name: FIBER, MEDICAL, ABSORBENT
• Manufacturer (Section D): US MEDCO INC.; 2900 wilcrest drive; suite 163; houston TX 77042
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1703 highway 33 south; new tazewell TN 37825
• Manufacturer Contact: reagan newman ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 19929609
• Report Number: 1060680-2023-00002
• Device Sequence Number: 18177996
• Product Code: FRL
• UDI-Device Identifier: 50749756677061
• UDI-Public: 50749756677061
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2023

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: DT04-B-M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/26/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 08/08/2024
• 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