MAUDE Adverse Event Report: BAXTER HEALTHCARE - AIBONITO VITALSHIELD V-LINK EXTENSION SETS WITH AMC; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	6N8378
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/20/2018
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 there was connection difficulty with two (2) v-link catheter extension sets.This issue occurred during setup with patient involvement.The retractable collar on the set device would not move forward to connect on the tubing.When the end user removed the cover to connect to patient through a catheter tubing, the luer lock on the device was observed to be stuck in its retracted position, and would not advance forward to secure on to the catheter at the distal end of the tubing.There was no damage or issues found on the product prior to using it.The issue was resolved, as they were able to use another set and make the connection and continue therapy.There was no patient injury or medical intervention associated with this event.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 returned; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: VITALSHIELD V-LINK EXTENSION SETS WITH AMC
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE - AIBONITO; aibonito
• MDR Report Key: 7345332
• Report Number: 1416980-2018-01391
• Device Sequence Number: 1393780
• Product Code: FPA
• UDI-Device Identifier: 00085412088341
• UDI-Public: (01)00085412088341
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K081289
• 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): 04/03/2018

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: Health Professional
• Device Expiration Date: 06/19/2020
• Device Catalogue Number: 6N8378
• Device Lot Number: UR17I13104
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/20/2018
• Supplement Date Received by Manufacturer: 03/27/2018
• Initial Report FDA Received Date: 03/16/2018
• Supplement Report FDA Received Date: 04/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CATHETER