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

Catalog Number 2C4040

Device Problem Fluid/Blood Leak (1250)

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

Event Date 10/28/2022

Event Type  malfunction  

Event Description

It was reported that a cysto/bladder irrigation set was leaking.This issue was further described as, ¿the leakage was occurred from the root of the spike¿.This issue was identified during priming.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

H10: the device was received for evaluation.Visual inspection was performed using the naked eye which observed a hole in the drip chamber housing in the upstream seal.A functional testing was performed including clear passage and pressure testing which revealed a leak in the affected area.The reported condition was verified.The cause of the condition was due to an assembly issue during the manufacturing process.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CYSTOSCOPY IRRIGATION SET
• Type of Device: SYSTEM, IRRIGATION, UROLOGICAL
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - CARTAGO; see h10; see h10; cartago 30106 ; CS 30106
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 15846964
• MDR Text Key: 306896628
• Report Number: 1416980-2022-06419
• Device Sequence Number: 1
• Product Code: LJH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K960787
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/22/2022

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 Operator: Other
• Device Catalogue Number: 2C4040
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/28/2022
• Initial Date FDA Received: 11/22/2022
• Supplement Dates Manufacturer Received: 12/16/2022
• Supplement Dates FDA Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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