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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 No Flow (2991)
Patient Problems High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914)
Event Date 02/05/2021
Event Type  Injury  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that during patient infusion of epinephrine with a one-link connector, a ¿clogged medication line¿ was observed.It was reported the patient ¿had to be treated for hypertension¿.It was reported a tubing change was performed.It was also reported the patient was given albumin bolus for hypotension.At the time of this report, the patient outcome was not reported.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.
 
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Brand Name
ONE-LINK NEUTRAL LUER ACTIVATED DEVICE
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key11453775
MDR Text Key238872410
Report Number1416980-2021-01187
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
PMA/PMN Number
K132734
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number7N8399
Device Lot NumberASKU
Was Device Available for Evaluation? No
Date Manufacturer Received04/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
MICRO-VOLUME EXTENSION SET; MICRO-VOLUME EXTENSION SET
Patient Outcome(s) Required Intervention;
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