MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-TL1LYR 14FR10ML LATEX DB SAFES

Catalog Number	URO170114Q
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported a "detached sample port" and stated, "pt ripped off sample port." medline quality received 1 ea of the reported product, and the product was received in unpackaged, used condition; visual assessment of the provided product revealed that the sample port valve had detached from its housing on the drainage bag tubing and remnants of the adhesive coating could be seen on the septum on the valve.The reported issue was verified by visual assessment of the provided product, thus confirming the reported complaint.Based on the provided sample and the description of the issue, the likely root cause is an inconsistency in adhesive application during sample port assembly; the manufacturing facility has been notified and corrective actions have been taken to address this issue.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.
Event or Problem Description
It was reported that "detached sample port" and "pt ripped off sample port.".

• Brand Name: MEDLINE
• Common Device Name: DBD-TL1LYR 14FR10ML LATEX DB SAFES
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: jarred meyers ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50778004
• Report Number: 1417592-2026-41250
• Device Sequence Number: 10664476
• Product Code: PPB
• UDI-Device Identifier: 40193489442121
• UDI-Public: 40193489442121
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 09/14/2026

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: URO170114Q
• Device Lot Number: 23KBA582
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/26/2024
• 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: 02/02/2024
• 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