MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK CHEMO-AIDE DISPENSING PIN; SET, I.V. FLUID TRANSFER

Catalog Number Z1MC3490

Device Problem No Flow (2991)

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

Event Type  malfunction  

Event Description

It was reported that an unspecified quantity of chemo-aide dispensing pins had no flow or limited flow of the drug through the spike.This was observed during use of the devices with cytostatic drugs.There was no patient involvement.No additional information is available.

Manufacturer Narrative

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

Manufacturer Narrative

Additional information: h3, h4, h6, h10.H4: the lot was manufactured in september 2023.H10: the actual devices were not available; however, companion samples were received for evaluation; seven carton boxes were returned (280 devices).Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional leak and air flow testing were performed; no issues were noted.The samples were determined to be conforming product.The reported condition was not verified on the companion samples.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 CHEMO-AIDE DISPENSING PIN
• Type of Device: SET, I.V. FLUID TRANSFER
• 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: 18723062
• MDR Text Key: 335599888
• Report Number: 1416980-2024-00618
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 04/04/2024

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: Z1MC3490
• Device Lot Number: 23H05T183
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2024
• Initial Date FDA Received: 02/16/2024
• Supplement Dates Manufacturer Received: 03/19/2024
• Supplement Dates FDA Received: 04/04/2024
• 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