MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; PARACENTESIS KIT

Catalog Number	DYNDH2053A
Medical Device Problem Codes	Restricted Flow rate (1248); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that ¿there were no identifiable visual defects noted with tubing.Only occurred when under pressure with suction that the tubing started to kink.¿ ¿the kink was so bad that it completely clamped down on itself and only a trickle of fluid was coming out.¿.
Additional Manufacturer Narrative
According to the customer, during a paracentesis procedure, the flow of fluid from the patient to the vacutainer was impacted when the tubing kinked, and efforts failed to restore the flow of fluid; the customer reported there was no serious injury, medical intervention, or follow-up care related to the reported incident.A photo and a sample were received for investigation, including three photos showing various kinks along the tubing and one used roller extension set with the tubing; there were multiple kinks within the tubing, the roller did not create any additional kinks, and the kinks present in the tubing did not straighten when the tubing was pulled.The vendor reviewed the sample provided and confirmed the reported issue.The vendor determined the kink was not caused by the use of the roller clamp, however they were unable to determine a true root cause; the complaint was entered into the vendor database for monitoring and trending, and no further action was taken by the vendor.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: PARACENTESIS KIT
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: pranay abbu ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50898748
• Report Number: 1417592-2026-51034
• Device Sequence Number: 17599567
• Product Code: LRO
• UDI-Device Identifier: 10198459226274
• UDI-Public: 10198459226274
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 09/24/2026

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: DYNDH2053A
• Device Lot Number: 25DBJ325
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/24/2025
• 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: 07/09/2025
• Initial Report FDA Received Date: 09/25/2026
• 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 Age: 58 YR
• Patient Sex: Male
• Patient Weight: 200 LB