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

Catalog Number ARC0473MP

Device Problems Fluid/Blood Leak (1250); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/09/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 a plexitron extension set "exploded" during a contrast medium injection which resulted in a leak of the drug.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional test is performed with satisfactory results, no obstruction in their assemblies was noted.The cause was due to a use error from the end user.Per the complaint description, the contrast media was applied using an injector device which uses a pressure of 325 psi.This practice is not recommended by baxter due to this product code is designed for manual application only.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 - CALI; cali
• Manufacturer (Section G): BAXTER HEALTHCARE - CALI; calle 36 no. 2c-22; apartado aero 2446; cali ; CO
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 8471494
• MDR Text Key: 140730302
• Report Number: 1416980-2019-01701
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07707141302767
• UDI-Public: (01)07707141302767
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/09/2019

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: Other
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: ARC0473MP
• Device Lot Number: SE17KQ3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2019
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/07/2019
• Initial Date FDA Received: 04/01/2019
• Supplement Dates Manufacturer Received: 04/12/2019
• Supplement Dates FDA Received: 05/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2017
• 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
• Patient Age: 46 YR