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

Catalog Number 2H6519

Device Problem Incomplete or Inadequate Connection (4037)

Patient Problem No Patient Involvement (2645)

Event Date 08/18/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported two (2) non-dehp continu-flo solution sets were unable to connect to an interlink system non-dehp y-type catheter extension set.It was further reported, when the distal end of the continu-flo solution set is connected to the interlink extension set¿s and the ¿luer is advanced, the luer does not feel secure and can spin back¿.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information: d10, h3 and h6.H10: two (2) devices were received for evaluation.During visual examination, both devices were observed connected to a interlink system non-dehp y-type catheter extension set.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing was completed, including pressure and clear passage under water testing, and the products performed according to product specifications.The reported condition was not verified.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 CORPORATION; deerfield IL
• MDR Report Key: 10532584
• MDR Text Key: 206929578
• Report Number: 1416980-2020-05689
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): Y
• PMA/PMN Number: K123868
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/22/2020

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
• Device Operator: Other
• Device Catalogue Number: 2H6519
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Initial Date Manufacturer Received: 08/18/2020
• Initial Date FDA Received: 09/14/2020
• Supplement Dates Manufacturer Received: 10/20/2020
• Supplement Dates FDA Received: 10/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1