MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK CONTINU-FLO BLOOD RECIPIENT SET; SET, BLOOD TRANSFUSION

Catalog Number FNC3220N

Device Problems Break (1069); Material Integrity Problem (2978)

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

Event Date 11/09/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that eight (8) continu-flo blood/soln sets had a broken port when the syringe was removed.This was discovered after use; however, patient involvement was not specified.After checking, the ports appeared to have bubbling in the plastic.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H4: the lot was manufactured in february 2023.H10: one sample was received for evaluation; the other seven (7) samples were not received and therefore, could not be evaluated.A visual inspection was performed which revealed a crack at level of the luer lock.The reported condition was verified.The cause was determined to be a raw material issue in the manufacturing process.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

H11: correcting the following fields to align with the product reported in d4: d1: brand name, d4: model #, d4: expiration date, d4: unique identifier (udi) #, g4: combination product.The d4: unique device identifier (udi) # is for the product reported in d4.This product code is sold/distributed outside the us, but is deemed same as or similar to product distributed in the us.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CLEARLINK CONTINU-FLO BLOOD RECIPIENT SET
• Type of Device: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - TUNISIA; route de chebbaou; 2021oued e; tunis ; TS
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 18270750
• MDR Text Key: 329806749
• Report Number: 1416980-2023-06338
• Device Sequence Number: 1
• Product Code: BRZ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/19/2024

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: Other
• Device Catalogue Number: FNC3220N
• Device Lot Number: 23C10T157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/09/2023
• Initial Date FDA Received: 12/05/2023
• Supplement Dates Manufacturer Received: 01/05/2024
• Supplement Dates FDA Received: 01/19/2024
• 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
• Treatment: UNSPECIFIED SYRINGE.