MAUDE Adverse Event Report: BAXTER HEALTHCARE - CARTAGO INTERLINK CONTINU-FLO STOPCOCK AND I.V. SOLUTION ADMINISTRATION SETS; STOPCOCK, I.V. SET

Catalog Number	3C0062
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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
This report summarizes 5 malfunction events.It was reported that the first port of five (5) interlink system continu-flo solution sets was collapsed and leaking.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
One single-use sample was receive for evaluation.The sample was returned contaminated with blood.A visual inspection was performed on the sample and the fourth y-site was found to have a collapsed septum.The reported condition was verified.The cause of the condition was determined to be an assembly issue during manufacturing.A batch review was conducted for lot r18h04062 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 STOPCOCK AND I.V. SOLUTION ADMINISTRATION SETS
• Common Device Name: STOPCOCK, I.V. SET
• Manufacturer (Section D): BAXTER HEALTHCARE - CARTAGO; cartago
• MDR Report Key: 8287611
• Report Number: 1416980-2019-00368
• Device Sequence Number: 16642016
• Product Code: FMG
• UDI-Device Identifier: 00085412017716
• UDI-Public: (01)00085412017716
• Combination Product (Y/N): N
• Number of Events Summarized: 5
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2019

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?: No
• Operator of Device: No Information
• Device Catalogue Number: 3C0062
• Device Lot Number: R18H04062
• Initial Date Received by Manufacturer: 12/31/2018
• Supplement Date Received by Manufacturer: 03/31/2019
• Initial Report FDA Received Date: 01/29/2019
• Supplement Report FDA Received Date: 04/29/2019
• Patient Sequence Number: 1