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 12/02/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The sample was received for evaluation.Visual inspection confirmed that the tubing part separated from the luer activated valve.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The reported condition was verified.The cause of the condition was related to a manufacturing issue.A nonconformance has been opened to address this issue.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a broken clearlink bag spike adapter was identified during priming.There was no patient involvement.No additional information is available.

• 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; piisa industrial park antigua; carretera sanchez km 18 1/2; haina san cristobal ; DR
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 7155481
• MDR Text Key: 96116181
• Report Number: 1416980-2017-10080
• 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
• Report Date: 12/29/2017

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: 12/21/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2017
• Initial Date FDA Received: 12/29/2017
• 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