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 Patient Involvement (2645)

Event Date 10/09/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that embedded particulate was discovered in an unspecified quantity of cysto/bladder irrigation sets.This was identified prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information was added to b3, b5, d10, h3, h4 and h6.B3: this event occurred on 10/09/2020, previously submitted as "asku" b5: during follow up, it was further clarified that the embedded particulate was on the outer part of the tubing.The affected quantity is three (3), previously submitted as "unspecified quantity".H10: three (3) actual samples were received for evaluation.Visual inspection was performed using the naked eye which observed irregular brown flecks embedded in the tubing on multiple areas of all samples.The reported condition was verified.The cause of the condition is manufacturing related.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
• MDR Report Key: 10792807
• MDR Text Key: 214798601
• Report Number: 1416980-2020-06886
• Device Sequence Number: 1
• Product Code: LJH
• UDI-Device Identifier: 00085412001050
• UDI-Public: (01)00085412001050
• Combination Product (y/n): Y
• PMA/PMN Number: K960787
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/08/2020

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: R20F22098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2020
• Initial Date Manufacturer Received: 10/12/2020
• Initial Date FDA Received: 11/05/2020
• Supplement Dates Manufacturer Received: 12/03/2020
• Supplement Dates FDA Received: 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1