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

Catalog Number 2H5660

Device Problem Incomplete or Inadequate Connection (4037)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that an unspecified ¿add on¿ 0.2 filter would ¿not fully secure¿ to the secondary set.It was further described that a secure connection could not be made because the ¿teeth of the secondary set were not fully sharp in order to secure the set¿ to the filter.This was identified while in use for a patient infusion.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The actual device was not available; however, a companion sample was received for evaluation.A visual inspection was performed which observed a rub mark with the outlet port of the filter causing the marks.The luer was functional tested and connected to a male luer which observed a non secure connection.Additional dimensional test was to the outlet port of the filter and observed that the product does not meet the product specifications.The reported problem was verified.The cause was deemed to be from the filter.The filter is a third party product.A nonconformance was requested from the supplier.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 ADMINISTRATION SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE - CARTAGO; cartago
• Manufacturer (Section G): BAXTER HEALTHCARE - CARTAGO; see h10; see h10; cartago 30106 ; CS 30106
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 8453084
• MDR Text Key: 140002146
• Report Number: 1416980-2019-01590
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412065328
• UDI-Public: (01)00085412065328
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K153158
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/27/2023
• Device Catalogue Number: 2H5660
• Device Lot Number: R18K27050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/28/2018
• 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