MAUDE Adverse Event Report: BAXTER HEALTHCARE ACCESS; SYSTEM, IRRIGATION, UROLOGICAL

Catalog Number 2C4040

Device Problem Device Packaging Compromised (2916)

Patient Problem No Patient Involvement (2645)

Event Date 07/28/2014

Event Type  malfunction  

Event Description

It was reported that the packaging of a bladder irrigation set did not open properly.One side of the packaging opened normally but the other side began to tear towards the center halfway through opening.The product was not used after the package did not open properly.There was no patient involvement.No additional information is available.

Manufacturer Narrative

(b)(4).The device was returned and the evaluation is ongoing.Should additional relevant information become available, a follow-up mdr will be submitted.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was received for evaluation.During visual inspection the packaging was observed to be torn from the seam at approximately the halfway point on one side.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The cause of the problem is unknown.A capa has been opened for this issue.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: ACCESS
• Type of Device: SYSTEM, IRRIGATION, UROLOGICAL
• Manufacturer (Section D): BAXTER HEALTHCARE; 600 mts oeste de entrada; cartago ; CS
• Manufacturer (Section G): BAXTER HEALTHCARE; 600 mts oeste de entrada; cartago ; CS
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 4031188
• MDR Text Key: 4804001
• Report Number: 1416980-2014-27652
• Device Sequence Number: 1
• Product Code: LJH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960787
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/27/2019
• Device Catalogue Number: 2C4040
• Device Lot Number: R14A27062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1