MAUDE Adverse Event Report: BAXTER HEALTHCARE - HAINA EXTENSION SETS WITH ONE-LINK NEEDLE-FREE LV CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	7N8377
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/22/2017
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 a one-link y-type catheter extension set ¿fell apart¿ the reporter stated that the y site disconnected from the tubing during infusion of 5% dextrose solution.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 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: EXTENSION SETS WITH ONE-LINK NEEDLE-FREE LV CONNECTOR
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE - HAINA; haina, san cristobal
• MDR Report Key: 7190855
• Report Number: 1416980-2018-00137
• Device Sequence Number: 10790925
• Product Code: FPA
• UDI-Device Identifier: 00085412091808
• UDI-Public: (01)00085412091808
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K132734
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2018

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: 09/14/2022
• Device Catalogue Number: 7N8377
• Device Lot Number: DR17I13054
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/22/2017
• Supplement Date Received by Manufacturer: 02/08/2018
• Initial Report FDA Received Date: 01/15/2018
• Supplement Report FDA Received Date: 02/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1