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

Catalog Number AZC7525

Device Problem Hole In Material (1293)

Patient Problem No Patient Involvement (2645)

Event Date 01/12/2018

Event Type  malfunction  

Manufacturer Narrative

The device was received for evaluation.During visual examination, a hole was observed in the set; however, since it was already outside the blister pack and had solution flow, it is not possible to say when the deviation occurred.The reported condition was verified; however, the cause of the condition could not be determined.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported a buretrol solution set was damaged.Prior to use, a hole was observed in the set.There was no patient involvement.No additional information is available.

• Brand Name: BURETROL SOLUTION 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: 7245101
• MDR Text Key: 99152539
• Report Number: 1416980-2018-00577
• 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: 02/06/2018

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 Catalogue Number: AZC7525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2018
• Initial Date FDA Received: 02/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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