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

Catalog Number 7N8399

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Unspecified Infection (1930)

Event Date 06/22/2016

Event Type  Injury  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

A patient experienced a central line associated blood stream infection (clabsi) which was reported to be due to a one-link neutral luer activated device (no further detail was provided).On an unreported date, the patient was admitted to an intensive care unit for an unrelated indication.A femoral line triple and arterial line were inserted.Three days later, the patient developed a fever of 38.1 centigrade.This occurred during the transfer of the patient to a kinair bed as which time the patient had symptoms of neurological storming.On an unspecified date, the patient was treated with unspecified (reported as ¿appropriated¿) antibiotics for clabsi (doses, frequencies, and routes were not reported).No further detail was provided regarding the patient¿s outcome from the event.No additional information is available.

Manufacturer Narrative

The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

A product use review was conducted with the hospital by baxter clinical services.The assessment revealed that scrubbing (antiseptic) of the device was not performed according to the package label instructions.It was stated in the assessment result, that "no scrubbing was performed when the device was removed from the packaging and in between multiple syringe accesses".Upon further review, it was determined that the reported condition of ¿central line associated blood stream infection (clabsi)¿ was due to use error and therefore, not a manufacturing related issue.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 - 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: 6667486
• MDR Text Key: 78407097
• Report Number: 1416980-2017-05282
• Device Sequence Number: 1
• Product Code: FPA
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7N8399
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 14 YR