MAUDE Adverse Event Report: BAXTER HEALTHCARE - DOMINICAN REPUBLIC CLEARLINK TRANSFER SET; SYSTEM/DEVICE, PHARMACY COMPOUNDING

Catalog Number 1C8687

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 11/09/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).One sample has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the spike adapter of six (6) clearlink blood bag spike adapters broke.This occurred during set-up/prime.There was no patient involvement.No additional information is available.

Manufacturer Narrative

One sample was received for evaluation.Visual inspection revealed that the tubing was separated from the luer activated valve.The reported condition was verified.The cause of the condition was determined to be a manufacturing issue.A nonconformance was opened to address this issue.The five (5) additional reported samples were not received for evaluation; therefore, a device analysis could not be performed.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 TRANSFER SET
• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; haina san cristobal
• Manufacturer (Section G): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; carretera sanchez km 18.5; parque industrial itabo, piisa; haina san cristobal ; DR
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 7101352
• MDR Text Key: 94378305
• Report Number: 1416980-2017-09678
• Device Sequence Number: 1
• Product Code: NEP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/08/2018

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 Expiration Date: 07/15/2022
• Device Catalogue Number: 1C8687
• Device Lot Number: DR17G14064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2017
• Initial Date FDA Received: 12/08/2017
• Supplement Dates Manufacturer Received: 12/27/2017
• Supplement Dates FDA Received: 01/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1