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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE - AIBONITO ONE-LINK NEUTRAL LUER ACTIVATED DEVICE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 7N8399
Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Fever (1858)
Event Date 03/07/2016
Event Type  Injury  
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.
 
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). A patient with severe pulmonary hypotension was admitted to the critical care unit (ccu) status post cardiac catheterization on. The next day, a right internal jugular pulmonary artery (ij pa) catheter remained in after the catheterization and a foley catheter was inserted in the ccu. Two days later, the foley was discontinued. The patient was transferred to a different unit on the next day with the pa line in place. Two days later, the patient developed a fever and blood cultures drawn that day which revealed e. Coli. On an unreported 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
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.
 
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Brand NameONE-LINK NEUTRAL LUER ACTIVATED DEVICE
Type of DeviceSET, 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 Key6663904
MDR Text Key78291910
Report Number1416980-2017-05226
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K132734
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/23/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number7N8399
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/29/2017
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

Patient Treatment Data
Date Received: 06/23/2017 Patient Sequence Number: 1
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