MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION INFUSOR; BAXTER HEALTHCARE CORPORATION

Catalog Number 2C1702KP

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 11/04/2020

Event Type  malfunction  

Manufacturer Narrative

The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the bladder of a small volume infusor was damaged (broken) during injection/mixing.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H10: the actual sample was received for evaluation.Visual inspection was performed using the naked eye which revealed that the bladder was ruptured.Microscopic inspection was performed to identify any issues that could have caused the rupture.No signs of abnormality were observed.The reported condition was verified.The cause of the condition was not determined; however, the most likely cause of the condition is manufacturing related.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: INFUSOR
• Type of Device: BAXTER HEALTHCARE CORPORATION
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10951289
• MDR Text Key: 219893898
• Report Number: 1416980-2020-07560
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412081441
• UDI-Public: (01)00085412081441
• Combination Product (y/n): Y
• PMA/PMN Number: K071222
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/30/2020

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: 2C1702KP
• Device Lot Number: 19K037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2020
• Initial Date Manufacturer Received: 11/10/2020
• Initial Date FDA Received: 12/05/2020
• Supplement Dates Manufacturer Received: 12/14/2020
• Supplement Dates FDA Received: 12/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1