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

Catalog Number JC4041P

Device Problem Defective Component (2292)

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

Event Date 04/09/2021

Event Type  malfunction  

Manufacturer Narrative

Device manufacturer address 1: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that an unspecified quantity of y-type tur/bladder irrigation sets appear to have very short spikes and as a result were very difficult to insert into the bags of solution.This was further described as the spike ¿barely made it past the seal which caused the tubing to twist at the connection and then the solution runs slowly¿.This was identified while attempting to spike bags of solution during unspecified process steps.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information was added to d4, d9, h3, h4 and h6.D4: the device returned had lot #: r20h01072; however, this lot could not be confirmed as one of the actual devices.Therefore lot #: r20h01072 will remain a potential lot number.H10: the device was received for evaluation.A visual inspection was performed using the naked eye did not identify any abnormalities that could have contributed to the reported condition.Functional testing was performed including clear passage and pressure testing; and the device performed according to product specifications.Additionally, priming was performed and no issues noted.The reported condition was not verified.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
• MDR Report Key: 11825833
• MDR Text Key: 250961467
• Report Number: 1416980-2021-02894
• Device Sequence Number: 1
• Product Code: LJH
• Combination Product (y/n): Y
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: JC4041P
• Device Lot Number: R20H01072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2021
• Date Manufacturer Received: 06/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED SOLUTION BAGS