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

Catalog Number	2C6537
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a continu-flo solution set had a disconnection issue.It was further reported the luer end of the tubing came off with the cap.This issue was identified during cap removal, prior to patient use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Additional information was added to h3, h4 and h6.H10: the actual device was not available; however, three (3) companion samples were received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.All components are correctly placed and according to specifications.A functional test tip protector removal was performed with no issues noted.A functional pressure test and clear passage test were also performed and no leaks nor block were noted.The reported condition was not verified.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
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 9484642
• Report Number: 1416980-2019-06971
• Device Sequence Number: 14449845
• Product Code: FPA
• UDI-Device Identifier: 00085412002248
• UDI-Public: (01)00085412002248
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K123868
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2020

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
• Operator of Device: Other
• Device Catalogue Number: 2C6537
• Device Lot Number: DR19E29056
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/22/2019
• Supplement Date Received by Manufacturer: 12/20/2019
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 01/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1