MAUDE Adverse Event Report: BAXTER HEALTHCARE - CARTAGO CLEARLINK LUER ACTIVATED VALVE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 2H8401

Device Problems Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 when the "slide or roller" clamp on a clearlink solution set was closed, it sliced the tubing and caused a leak.This was identified while in use on a patient to deliver an unspecified chemotherapeutic drug with an infusion pump.The reporter stated that there was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Correction : (initial reporter first name corrected, previously reported as jun) additional information : the actual sample was received and evaluated.The sample was contaminated with chemotherapy.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.No functional testing was performed due to the status of the returned sample.The reported problem was not verified.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: CLEARLINK LUER ACTIVATED VALVE
• 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: 8202514
• MDR Text Key: 131606131
• Report Number: 1416980-2018-08050
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412049090
• UDI-Public: (01)00085412049090
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112893
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/26/2023
• Device Catalogue Number: 2H8401
• Device Lot Number: R18F26051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2018
• 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
• Treatment: CHEMOTHERAPY DRUG; FLOGARD PUMP