MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK CONTINU-FLO SOLUTION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number JC8386

Device Problems Disconnection (1171); Incomplete or Inadequate Connection (4037)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

E1: initial reporter phone no.(additional): (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that an unspecified quantity of clearlink system continu-flo solution sets could not be connected properly to unspecified calcium chloride pre-filled syringes.This was observed during an unspecified process step.For an event, after screwing the syringe onto the entry port, the syringe popped out leaving the luer lock ring on the entry port of the set.When trying to push back the syringe through the entry port there was too much pressure; the user could not make the connection long enough to be able to push the plunger.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection of the provided photograph was performed; however, the reported condition could not be clearly observed in the photograph.Based on the nature of the sample, no additional testing was performed.The cause of the reported condition could not be determined.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 CONTINU-FLO SOLUTION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; carretera sanchez km 18.5; parque industrial itabo, piisa; haina, san cristobal 91000 ; DR 91000
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 16986631
• MDR Text Key: 315830468
• Report Number: 1416980-2023-02506
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412152691
• UDI-Public: (01)00085412152691
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: JC8386
• Device Lot Number: DR22I30079
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/03/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CALCIUM CHLORIDE PRE-FILLED SYRINGES