MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-HAND FOOT PACK

Catalog Number	DYNJ44273I
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "had 2 instances today of lot# 25bdb486 having what appears to be mold found in the suction tubing included in the pack.Due to the placement of the black discoloration, it gives the appearance of moisture settling in the tubing, as the black spots are all in the same curve of the coil and same side of the tubing.".
Additional Manufacturer Narrative
The account reported finding foreign matter in tubing, and photos depicted suction tubing with black stains or residue.A photo and a sample were received; two unopened packs were opened and both sets of suction tubing were reviewed, finished good production records were reviewed, and the finished good pack build was reviewed.The reported problem was confirmed: the samples were noted to contain black stains on certain sections, and the presence of dark staining on the coils of the tubing was confirmed.Based on the sample and pack build review, the black staining on the suction tubing was the result of ink transfer from the drape which the tubing is placed directly on top; the impacted tubing may be used as intended, and the quality team will monitor this issue for trending purposes.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: DBD-HAND FOOT PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: herchelle teodoro ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50772582
• Report Number: 1417592-2026-40427
• Device Sequence Number: 21467199
• Product Code: OJH
• UDI-Device Identifier: 10195327533731
• UDI-Public: 10195327533731
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/10/2026

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 Catalogue Number: DYNJ44273I
• Device Lot Number: 25BDB486
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/12/2025
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 09/15/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown