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

Catalog Number JC4040

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Type  malfunction  

Manufacturer Narrative

G1: device manufacturer address 1: 600 mts.Oeste de entrada, principal ave.Las americas, parque industrial should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a cysto/bladder irrigation set had a black mark on the inner portion of the tubing which looked burnt.This issue was discovered when opening the device package.There was no patient involvement.No additional information is available.

Manufacturer Narrative

D4: expiration date: january 2028.H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.A visual inspection was performed to the photograph using the naked eye which revealed a brown particle embedded between the walls of the tubing, which was noted to be a degraded piece of burned plastic.Due to the nature of the sample no additional tests could be performed.The reported condition was verified.The cause of the reported condition was a manufacturing related issue.This issue is not likely to cause or contribute to a death or serious injury as particulate matter outside of the fluid path does not impact the product delivered to the patient.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: 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: 16809908
• MDR Text Key: 313959553
• Report Number: 1416980-2023-01987
• Device Sequence Number: 1
• Product Code: LJH
• UDI-Device Identifier: 00085412042695
• UDI-Public: (01)00085412042695
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: JC4040
• Device Lot Number: R23A19062
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/23/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/19/2023
• 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