MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION TUR IRRIGATION SET; SYSTEM, IRRIGATION, UROLOGICAL

Catalog Number VMC4005

Device Problems Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that the tubing separated from the y-connector of a uromatic y type tur set which resulted in a fluid leak.This issue was further described as, ¿immediately upon taking them and getting ready to connect the connection of one of the ends that goes towards the liquids, it came off directly from the y; spilling all the liquid already connected¿.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

E1: initial reporter last name: (b)(6).E1: initial reporter first name: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

H10: the actual device was received for evaluation.A visual inspection of the actual sample using the naked eye identified one of the tubes was disconnected from the y-connector.A minimal amount of residual solvent was present on the tube.The reported condition was verified on the actual sample.The cause of the condition was determined to be related to improper solvent application during manufacturing.Additionally, two (2) retention samples were evaluated at the plant.The samples underwent visual inspection with the naked eye and no defects were noted.All junctions on the retention samples underwent a push-pull test and no disconnections were noted.Underwater leak and air passage testing were performed and no leaks or blockages were found.The reported condition was not verified on the retention samples.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: TUR IRRIGATION SET
• Type of Device: SYSTEM, IRRIGATION, UROLOGICAL
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - MALTA; a47 industrial estate; 2021oued e; marsa ; MT
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 18335096
• MDR Text Key: 330601541
• Report Number: 1416980-2023-06554
• Device Sequence Number: 1
• Product Code: LJH
• UDI-Device Identifier: 05413760232324
• UDI-Public: (01)05413760232324
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: VMC4005
• Device Lot Number: 22K23V492
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Sex: Male