MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEALINK BLOOD RECIPIENT SET; SET, BLOOD TRANSFUSION

Catalog Number FNC1172

Device Problems Fluid/Blood Leak (1250); Material Perforation (2205)

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

Event Date 03/10/2022

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the drip chamber a of clearlink y-type blood set was perforated which resulted in a leak.This issue was identified during infusion of sodium chloride 0.9% while doing a procedure to a patient in the intensive care unit (icu).There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Correction b5: additional information was received stating the issue was identified ¿before¿ the patient infusion (previously reported as ¿during infusion¿).H10: the actual device was not available; however, a video of the sample was provided for evaluation.Visual inspection was performed using the naked eye which observed a leakage from the hand pump.The reported condition was verified.The cause of the condition was due to a manufacturing related issue.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: CLEALINK BLOOD RECIPIENT SET
• Type of Device: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - SINGAPORE; 2 woodlands industrial park d; singapore 73875 0; SN 738750
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 13995506
• MDR Text Key: 288521090
• Report Number: 1416980-2022-01546
• Device Sequence Number: 1
• Product Code: BRZ
• UDI-Device Identifier: 00085412068879
• UDI-Public: (01)00085412068879
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: FNC1172
• Device Lot Number: SR20J30101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: No
• 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: SODIUM CHLORIDE