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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION ONE-LINK NEUTRAL LUER ACTIVATED DEVICE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 7N8399
Device Problem Disconnection (1171)
Patient Problem Hypoglycemia (1912)
Event Date 04/28/2021
Event Type  Injury  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that during a pediatric patient infusion of total parenteral nutrition (tpn) with a one-link needle free connector, a disconnection was found. The event was further specified as the large volume tpn tubing was disconnected from the one-link cap on the manifold. Subsequently, the patient experienced hypoglycemia. The patient received a d50w bolus for the event. The cause of the disconnection was not reported. Ivf replacement (tpn) tubing was requested. At the time of this report, the nurse reported the patient outcome as they believe that the bolus ¿fixed¿ the hypoglycemia (no further details). No additional information is available.
 
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Brand NameONE-LINK NEUTRAL LUER ACTIVATED DEVICE
Type of DeviceSET, 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 
2242702068
MDR Report Key11952457
MDR Text Key256191940
Report Number1416980-2021-03430
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K132734
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number7N8399
Device Lot NumberASKU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/12/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/07/2021 Patient Sequence Number: 1
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