MAUDE Adverse Event Report: PREFERRED MEDICAL PRODUCTS, LLC DECANTER 50C; CONTAINER, I.V.

Model Number	77-400274
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility reported with a medwatch (#(b)(4)), "tips broke off in fluid bag.".
Additional Manufacturer Narrative
A user facility reported with a medwatch (#(b)(4), "tips broke off in fluid bag." deroyal industries, inc.Requested return of the device, but it has not yet been received.A supplier corrective action request (scar) will be issued to the supplier, medline.This investigation is not complete at this time.No further information is available at this time.We will provide follow up information when additional information becomes available.
Additional Manufacturer Narrative
A user facility reported with a medwatch (b)(4), "tips broke off in fluid bag." deroyal industries, inc.Requested return of the device, and it was received on 10/01/2025.The sample was reviewed by quality assurance and confirmed that the tip was broken off.It was originally stated that a supplier corrective action request (scar) was issued to the supplier, medline, but the supplier was incorrectly listed.The correct supplier is preferred medical products, llc.The supplier reviewed the incoming inspections and all device history records for lot numbers n28094 including returned samples.All specifications were met.No design or specification change from preferred medical products has been made in the past 30 years.Root cause: no specific root cause was able to be determined.Potential root causes: one potential root cause is a change to the saline bag.The bag decanter is designed to be used in conjunction with multiple saline bag manufacturers; however, the design cannot account for their changes in materials or designs.Another potential root cause could be a usage error is which too much angle or pressure could have been applied to the tip during application.Corrective or preventive action: because no specific root cause could be determined, no corrective or preventive actions were taken.Deroyal will continue monitor for trends around this item and issue.This investigation is complete at this time.No further information is available at this time.We will provide follow up information if additional information becomes available.

• Brand Name: DECANTER 50C
• Common Device Name: CONTAINER, I.V.
• Manufacturer (Section D): PREFERRED MEDICAL PRODUCTS, LLC; 191 industrial drive; p.o. box 100; ducktown TN 37326 7758
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC..; 1501 east central avenue; lafollette TN 37766
• Manufacturer Contact: reagan facemire ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 23144787
• Report Number: 3005011024-2025-00014
• Device Sequence Number: 12973473
• Product Code: KPE
• UDI-Device Identifier: 00749756281928
• UDI-Public: 00749756281928
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K811233
• 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): 10/14/2025

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: Health Professional
• Device Model Number: 77-400274
• Device Lot Number: 62370824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/25/2025
• Supplement Report FDA Received Date: 10/15/2025
• 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