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

Catalog Number 2C8541

Device Problems Component Missing (2306); Material Deformation (2976)

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

Event Date 06/13/2023

Event Type  malfunction  

Manufacturer Narrative

D4: lot #: the suspect lot was either r23c07017 or r23d03024.G1: device manufacturer address 1: 600 mts.Oeste de entrada, principal ave.Las americas, parque industrial.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a clearlink system continu-flo solution set was damaged.The luer lock appeared to be defective, as it was shorter than usual.This was identified during preparation, when the nurse was about to spike the intravenous (iv) fluids.Additionally, the blue end cap was missing; the luer lock was not protected.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H4: lot r23c07017, expiration date: march 8, 2025 was manufactured on march 09, 2023 h4: lot r23d03024, expiration date april 4, 2025 was manufactured on april 05.2023.H10: the actual device was not available; however, three (3) photographs of the sample were provided for evaluation.A visual inspection was performed to the photographs using the naked eye which revealed the luer lock appeared to be defective as it was shorter than usual.Additionally, the luer lock was not protected with a blue cap as it normally is (in the packaging).The reported conditions were verified.The cause of the conditions were manufacturing related due to a short shot at the two piece luer lock body which could be produced by an incorrect closure of the mold (damaged at the cavities) or an incorrect set up of the molding machine with an incorrect segregation of the affected material.The cause of the missing component is a separation per the short shot at the two piece luer lock body.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.

Manufacturer Narrative

H10: the device was received for evaluation.A visual inspection was performed and the luer lock assembly was observed malformed and the luer lock was not protected with a blue cap.The reported conditions were verified.The cause of the conditions were manufacturing related due to a short shot at the two piece luer lock body which could be produced by an incorrect closure of the mold (damaged at the cavities) or an incorrect set up of the molding machine with an incorrect segregation of the affected material.The cause of the missing component is a separation per the short shot at the two piece luer lock body.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• 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: 17298326
• MDR Text Key: 319695560
• Report Number: 1416980-2023-03463
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203609
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/14/2023

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: Health Professional
• Device Catalogue Number: 2C8541
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/14/2023
• Initial Date FDA Received: 07/11/2023
• Supplement Dates Manufacturer Received: 08/08/2023; 09/05/2023
• Supplement Dates FDA Received: 08/10/2023; 09/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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