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

Catalog Number	2H6519
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported the iv tubing of 2 non-dehp continu-flo solution sets popped off at the screw-on collar.The event was further reported as "the collar does not engage, just keeps spinning around and not tightening".The event occurred prior to attaching to the patient; therefore, there was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.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: 10505878
• Report Number: 1416980-2020-05545
• Device Sequence Number: 11521467
• Product Code: FPA
• UDI-Device Identifier: 00085412000527
• UDI-Public: (01)00085412000527
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• 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,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2020

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: 2H6519
• Device Lot Number: R19C30042
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/12/2020
• Supplement Date Received by Manufacturer: 09/25/2020
• Initial Report FDA Received Date: 09/08/2020
• Supplement Report FDA Received Date: 10/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1