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

Catalog Number	2C4040
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that particulate matter (pm) was embedded within the tubing of an unspecified quantity of cysto/bladder irrigation sets.The pm was discovered prior to patient use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
H10: the actual devices were not available; however, photographs of the sample were provided for evaluation.Visual inspection of the photographs was performed using the naked eye which observed embedded particulate inside the tubing.The particulate was further described as irregular brown flecks embedded in multiple areas of the tubing; most likely due to degraded pieces of burned plastic.The reported condition was verified.The cause of the condition could not be determined; however, the most probable cause was due to the extrusion process during manufacturing.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.
Additional Manufacturer Narrative
Three (3) unused devices were received for evaluation.A visual inspection was performed and irregular brown flecks were observed embedded in the tubing on multiple areas.The reported condition was verified.The cause of the condition could not be determined; however, the most probable cause was due to the extrusion process during manufacturing.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CYSTOSCOPY IRRIGATION SET
• Common Device Name: SYSTEM, IRRIGATION, UROLOGICAL
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11091605
• Report Number: 1416980-2020-08178
• Device Sequence Number: 16959213
• Product Code: LJH
• UDI-Device Identifier: 00085412001050
• UDI-Public: (01)00085412001050
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K960787
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/12/2021

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
• Operator of Device: Other
• Device Catalogue Number: 2C4040
• Device Lot Number: R20E27214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Initial Date Received by Manufacturer: 12/04/2020
• Supplement Date Received by Manufacturer: 01/29/2021; 05/07/2021
• Initial Report FDA Received Date: 12/29/2020
• Supplement Report FDA Received Date: 02/01/2021; 05/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1