MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; KIT,SPECI-CATH,PED,5FR,9IN,PVP,LUB,GLV

Catalog Number	DYND10820H
Medical Device Problem Codes	Filling Problem (1233); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "we are still encountering problems with the 5 & 8 fr cath tubes not filling up but then the patient ends up urinating around the tube.".
Additional Manufacturer Narrative
Medline quality received a complaint regarding the urine collection tubes not filling and leaking around the catheter with respect to the speci-cath kits, 5 fr & 8 fr.Medline quality received 3 ea of the reported product in unpackaged, used condition, and an assessment of the returned sample was conducted based on established inspection criteria; visual assessment revealed no defects nor abnormalities, measurement of catheter dimensions met the specified product criteria, and no obstructions were found within the drainage lumen of the catheters.The reported issue of poor drainage and leakage could not be verified based on inspection of the received sample.Based on assessment of the samples received and the information reported, this indicates that the issue is not due to a product defect; this complaint will be closed as "not a product defect: customer caused," and the cause code was adjusted to "dc: traced to user with misuse/mishandling." 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: KIT,SPECI-CATH,PED,5FR,9IN,PVP,LUB,GLV
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: narendra nambula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50946435
• Report Number: 1417592-2026-54253
• Device Sequence Number: 21215937
• Product Code: EZD
• UDI-Device Identifier: 10080196028894
• UDI-Public: 10080196028894
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K172541
• 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): 09/28/2026

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: DYND10820H
• Device Lot Number: 96924100002
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/15/2025
• 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: 05/05/2025
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (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