MAUDE Adverse Event Report: BAXTER HEALTHCARE - AIBONITO INTERLINK SYSTEM T-CONNECTOR EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	2N3326
Medical Device Problem Codes	Fluid/Blood Leak (1250); Tear, Rip or Hole in Device Packaging (2385); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event occurred on an unspecified date in (b)(6) 2018.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the packaging was damaged and the tubing of an interlink system t-connector extension set was cut and sticking out of the packaging through the side seal.This was noted prior to use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
The actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection of the photograph revealed that a part of the set was trapped in the seal area.The reported condition was verified.The cause of the condition was determined to be a manufacturing issue.A batch review was conducted and it was found that during manufacturing, blisters with sets cut or trapped in the seal area of the blister during the packaging process were identified and discarded.Awareness training was provided to involved personnel.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: INTERLINK SYSTEM T-CONNECTOR EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE - AIBONITO; aibonito
• MDR Report Key: 7969344
• Report Number: 1416980-2018-06565
• Device Sequence Number: 1572549
• Product Code: FPA
• UDI-Device Identifier: 00085412004648
• UDI-Public: (01)00085412004648
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K060074
• 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): 11/15/2018

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: Other
• Device Expiration Date: 06/17/2023
• Device Catalogue Number: 2N3326
• Device Lot Number: UR18F17068
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/19/2018
• Supplement Date Received by Manufacturer: 11/05/2018
• Initial Report FDA Received Date: 10/16/2018
• Supplement Report FDA Received Date: 11/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1