MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ONE-LINK NEUTRAL LUER ACTIVATED DEVICE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 7N8399

Device Problems Crack (1135); Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Event date ¿ this issue occurred on an unspecified date during the week of march 8th.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a one-link needle-free iv connector was leaking contrast from between the connection of the clave hub and the catheter/needle hub.This issue was further described as, ¿baxter claves will actually ¿crack¿ if turned too tight, or if you actually turn past the junction, it remains loose¿.The leak was observed while injecting contrast at 3.0-5.0 flow rate.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H10: 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 discarded; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: ONE-LINK NEUTRAL LUER ACTIVATED DEVICE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• 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: 16685768
• MDR Text Key: 312735666
• Report Number: 1416980-2023-01592
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412091785
• UDI-Public: (01)00085412091785
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7N8399
• Device Lot Number: UR22B12116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2023
• Date Device Manufactured: 02/17/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CONTRAST; UNSPECIFIED INTRAVENOUS THERAPY