MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PLEXITRON EXTENSION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number ARC0473MP

Device Problem Fitting Problem (2183)

Patient Problem No Patient Involvement (2645)

Event Date 11/09/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the luer lock of a plexitron extension set would not twist to make a connection.This issue was identified during setup and preparation prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H10: the device was received for evaluation.Visual inspection was performed, which observed a plasticization between the two (2) pieces.And it could not be rotated.Additionally, an absence of solvent was observed, where the pieces were fastened.The reported condition was verified.The cause of the condition could not be determined.However, the most probable cause 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: PLEXITRON EXTENSION SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11127109
• MDR Text Key: 225563750
• Report Number: 1416980-2020-08362
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07707141302767
• UDI-Public: (01)07707141302767
• Combination Product (y/n): Y
• PMA/PMN Number: NA
• 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: 02/11/2021

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: ARC0473MP
• Device Lot Number: SE20GE4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 01/06/2021
• Supplement Dates Manufacturer Received: 02/11/2021
• Supplement Dates FDA Received: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1