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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that particulates were observed in the tubing of one-hundred-fifty-five (155) cysto/bladder irrigation sets.This was observed prior to use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
H10: the actual devices were not available; however, a photograph of a device was provided for evaluation.A visual inspection of the photograph was performed using the naked eye which observed irregular brown flecks embedded in tubing on multiple areas due to degraded pieces of burned plastic outside the tubing.The embedded particulate outside of the fluid path would not impact the product delivered to the patient.The reported condition was verified on the photograph provided.The cause of the condition was due to burned resin from 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
Additional information was added to d9, h3 and h6.H10: one hundred fifty-five (155) unused devices were received for evaluation.During visual inspection particulate matter (pm) were observed in 69 units.The pm was outside the tubing.The pm was further analyzed and described as under 0.4 sq.Mm(which is within specifications), irregular and red flecks embedded on multiples areas.The pm was embedded; subsequently, it was not in the fluid path.Therefore, the reported condition was not verified.Visual inspection did not identify any abnormalities that could have contributed to the reported condition in the remaining 86 devices.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: 11812358
• Report Number: 1416980-2021-02842
• Device Sequence Number: 16956265
• Product Code: LJH
• UDI-Device Identifier: 00085412001050
• UDI-Public: (01)00085412001050
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K960787
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/02/2021

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: 08/12/2021
• Initial Date Received by Manufacturer: 04/19/2021
• Supplement Date Received by Manufacturer: 06/17/2021; 08/30/2021
• Initial Report FDA Received Date: 05/12/2021
• Supplement Report FDA Received Date: 06/18/2021; 09/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1