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 05/30/2018

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a solution set was noticed to be damaged.A hole was observed in the set during priming.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The device was received for evaluation.A visual inspection was performed and noted a hole in the tubing.Leakage and flow testing were also performed and a leak was observed.The reported condition was verified.The cause was determined.To be a manufacturing issue.A nonconformance has been opened to address this issue.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: 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: 7639736
• MDR Text Key: 112590162
• Report Number: 1416980-2018-03870
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05413765414954
• UDI-Public: (01)05413765414954
• 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,Followup
• Report Date: 08/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/24/2023
• Device Catalogue Number: AZC9697
• Device Lot Number: PE68S4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2018
• 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