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

Catalog Number 2C4040

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

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

Event Date 10/06/2022

Event Type  malfunction  

Manufacturer Narrative

Device manufacturer address 1: (b)(4).Parque industrial should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that particulate matter (pm) was observed within the tubing of a cysto/bladder irrigation set.The pm was further described as debris inside the tubing that appeared as a bug cooked during sterilization.This issue was identified before use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H10: the device was received for evaluation.A visual inspection was done which observed contamination-pm (particulate matter) outside the fluid path, between the walls of the tubing.A laboratory analysis was performed which revealed the particulate as, black embedded degraded pieces of burned plastic resin in the tubing.The reported condition of pm was verified.The cause of the condition was due to a manufacturing issue during the extrusion process.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: 15737629
• MDR Text Key: 306518550
• Report Number: 1416980-2022-06028
• Device Sequence Number: 1
• Product Code: LJH
• UDI-Device Identifier: 00085412001050
• UDI-Public: (01)00085412001050
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960787
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C4040
• Device Lot Number: R22D02130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2022
• 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