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

Catalog Number 2N3326

Device Problems Fluid/Blood Leak (1250); Tear, Rip or Hole in Device Packaging (2385); Material Split, Cut or Torn (4008)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

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 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.

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
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE - AIBONITO; aibonito
• Manufacturer (Section G): BAXTER HEALTHCARE - AIBONITO; rd 721 km 0 3 po box 1389; aibonito 00705
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 7969344
• MDR Text Key: 124356061
• Report Number: 1416980-2018-06565
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412004648
• UDI-Public: (01)00085412004648
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060074
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Other
• Device Expiration Date: 06/17/2023
• Device Catalogue Number: 2N3326
• Device Lot Number: UR18F17068
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2018
• Initial Date FDA Received: 10/16/2018
• Supplement Dates Manufacturer Received: 11/05/2018
• Supplement Dates FDA Received: 11/15/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1