MAUDE Adverse Event Report: BAXTER HEALTHCARE - SAO PAULO SOLUTION ADMINISTRATION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number AZC9697

Device Problem Hole In Material (1293)

Patient Problem No Patient Involvement (2645)

Event Date 01/04/2018

Event Type  malfunction  

Manufacturer Narrative

A sample was received for evaluation.Visual and functional testing noted a hole in the extension of the tube, causing a leak when submitted to solution flow.The reported issue was verified.The cause was not determined.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.

Event Description

It was reported that a hole was discovered in solution administration set.This was found before use.There was no patient involvement.No additional information is available.

• Brand Name: SOLUTION ADMINISTRATION SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE - SAO PAULO; sao paulo
• Manufacturer (Section G): BAXTER HEALTHCARE - SAO PAULO; av. alfredo egidio de souza; aranha, 100, bloco c; sao paulo 47261 70; BR 4726170
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 7226376
• MDR Text Key: 98776213
• Report Number: 1416980-2018-00425
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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
• Report Date: 01/29/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 08/04/2022
• Device Catalogue Number: AZC9697
• Device Lot Number: PE65R2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/04/2018
• Initial Date FDA Received: 01/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2017
• 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