MAUDE Adverse Event Report: BAXTER HEALTHCARE - DOMINICAN REPUBLIC CONTINU-FLO INTERLINK SYSTEM; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 2C6537

Device Problems Hole In Material (1293); Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 09/08/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a hole was identified in a continu-flo tubing set that caused iv solution to leak during priming.There was no patient involvement.No additional information was available.

Manufacturer Narrative

The device was received for evaluation.During visual inspection, a cut was observed in the tubing.The reported condition was verified.The cause of the event was due to a manufacturing issue found in a component of the device.Detection of this component was not identified and therefore the component was not removed from the manufacturing process.A nonconformance has been opened to address this 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: CONTINU-FLO INTERLINK SYSTEM
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 6911353
• MDR Text Key: 88061099
• Report Number: 1416980-2017-07998
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123868
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/03/2017

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: 11/24/2021
• Device Catalogue Number: 2C6537
• Device Lot Number: DR16K24083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2017
• Initial Date FDA Received: 10/03/2017
• Supplement Dates Manufacturer Received: 10/16/2017
• Supplement Dates FDA Received: 11/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2016
• 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