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

Catalog Number VMC4005

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

This event occurred during the unspecified date of (b)(6) 2019.(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the uromatic y type tur set "sticks to the outer packaging so the product cannot be taken out of the package in a sterile manner".This was identified prior to patient use; therefore, there was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information : correction to the previously submitted date.Baxter aware date is august 21, 2019 previously submitted as august 20, 2019.The device was received for evaluation.Visual inspection was performed and observed that the inner bag of the set sticks to the outer packaging.The reported condition was verified.The cause of the condition was found to be related to a human production issue 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.

• Brand Name: TUR IRRIGATION SET
• Type of Device: SYSTEM, IRRIGATION, UROLOGICAL
• Manufacturer (Section D): BAXTER HEALTHCARE - TUNISIA; tunis
• Manufacturer (Section G): BAXTER HEALTHCARE - TUNISIA; route de chebbaou; 2021oued e; tunis ; TS
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 9039395
• MDR Text Key: 158883385
• Report Number: 1416980-2019-05027
• Device Sequence Number: 1
• Product Code: LJH
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: VMC4005
• Device Lot Number: 18K10T431N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1