MAUDE Adverse Event Report: BAXTER HEALTHCARE - CARTAGO INTERLINK CONTINU-FLO SOLUTION ADMINISTRATION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	2C6571
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/28/2018
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 that an interlink continu-flo solution administration set had a foreign object inside the tubing.The event was observed prior to patient use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Additional information : the device was not received; however photographs were available for evaluation.Photographic inspection was performed and a dark particle was observed.Further analysis determined the particle to be burned resin.The reported condition was verified.The cause of the condition was related to the machine during the manufacturing process.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: INTERLINK CONTINU-FLO SOLUTION ADMINISTRATION SETS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE - CARTAGO; cartago
• MDR Report Key: 8190136
• Report Number: 1416980-2018-07976
• Device Sequence Number: 16804506
• Product Code: FPA
• UDI-Device Identifier: 00085412002279
• UDI-Public: (01)00085412002279
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K153158
• 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): 01/31/2019

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 Expiration Date: 03/16/2023
• Device Catalogue Number: 2C6571
• Device Lot Number: R18C16075
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/28/2018
• Supplement Date Received by Manufacturer: 01/26/2019
• Initial Report FDA Received Date: 12/21/2018
• Supplement Report FDA Received Date: 01/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1