MAUDE Adverse Event Report: BAXTER HEALTHCARE - CARTAGO TUR IRRIGATION SET; SYSTEM, IRRIGATION, UROLOGICAL

Catalog Number	2C4005
Medical Device Problem Code	Device Packaging Compromised (2916)
Health Effect - Clinical Code	No Patient Involvement (2645)
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 the sterile packaging of three (3) y-type tur irrigation sets was open.This event was discovered before patient use during the kitting process.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Two devices were received for evaluation.During visual examination, the pouch was observed open; therefore, the peel and seal width test was performed to evaluate the quality of the seal.The results were satisfactory due to the sealed is uniformed across the sealed area.Also, it was observed that the packaging material is correctly aligned.The reported condition was verified; however, the cause of the condition could not be determined.There are controls in place to detect and prevent an opening packaging in the manufacturing.The third device was not returned for evaluation; therefore, a device analysis could not be completed.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: TUR IRRIGATION SET
• Common Device Name: SYSTEM, IRRIGATION, UROLOGICAL
• Manufacturer (Section D): BAXTER HEALTHCARE - CARTAGO; cartago
• MDR Report Key: 7284494
• Report Number: 1416980-2018-00912
• Device Sequence Number: 1028956
• Product Code: LJH
• UDI-Device Identifier: 00085412000978
• UDI-Public: (01)00085412000978
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2018

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: 07/18/2022
• Device Catalogue Number: 2C4005
• Device Lot Number: R17G18057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2018
• Initial Date Received by Manufacturer: 01/25/2018
• Supplement Date Received by Manufacturer: 03/12/2018
• Initial Report FDA Received Date: 02/20/2018
• Supplement Report FDA Received Date: 03/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1