MAUDE Adverse Event Report: BAXTER HEALTHCARE - CARTAGO 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	03/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Contact office: (b)(4).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a hair was discovered within the packaging of a cysto/bladder irrigation set.This event was discovered during an unspecified process step before patient use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
The device was received for evaluation.A batch review was conducted and there were no deviations found related to the reported condition during the manufacture of this lot.Visual inspection was performed on the returned unit via the naked eye.The reported condition was verified due to a loose particle found inside the product pouch.The particle was concluded to be a hair.The possible cause was incorrect manufacturing practices during the manual assembly process.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 - CARTAGO; cartago
• MDR Report Key: 7394190
• Report Number: 1416980-2018-01836
• Device Sequence Number: 13879354
• Product Code: LJH
• UDI-Device Identifier: 00085412001050
• UDI-Public: (01)00085412001050
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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
• Report Date (Section B): 05/08/2018

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 Expiration Date: 06/14/2022
• Device Catalogue Number: 2C4040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2018
• Initial Date Received by Manufacturer: 03/09/2018
• Supplement Date Received by Manufacturer: 04/30/2018
• Initial Report FDA Received Date: 04/03/2018
• Supplement Report FDA Received Date: 05/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1