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

Catalog Number EMC9608

Device Problems Material Deformation (2976); Material Split, Cut or Torn (4008)

Patient Problem No Patient Involvement (2645)

Event Date 03/02/2020

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 administration set had a split in the tubing and kinks were evidenced in the line.This was identified when administering fluids through the line prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The actual sample was received for evaluation.Visual inspection was performed using the naked eye which observed a slit on the tubing.Further inspection of the tube revealed the point were the tube was torn, was thin.The reported condition was verified.The most probable cause of the condition was determined to be due to the packaging machine during the manufacturing process.A companion sample was also received.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.The reported condition was not verified on the companion sample.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 SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - MALTA; a47 industrial estate; marsa ; MT
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 9889311
• MDR Text Key: 185248831
• Report Number: 1416980-2020-01785
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 04/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: EMC9608
• Device Lot Number: 19G11V140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2020
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1