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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ONE-LINK NON-DEHP MICROBORE CATHETER EXTENSION SET, ADMINISTRATION, INTRAVASCULAR

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BAXTER HEALTHCARE CORPORATION ONE-LINK NON-DEHP MICROBORE CATHETER EXTENSION SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 7N8300
Device Problems Contamination (1120); Leak/Splash (1354); Loose or Intermittent Connection (1371)
Patient Problems Chemical Exposure (2570); No Known Impact Or Consequence To Patient (2692)
Event Date 09/28/2017
Event Type  malfunction  
Event Description
Iv hub on patient intermittent needle therapy (int), came loose while injecting with radiopharmaceutical. Causing a small amount of contamination. Late september: we did not save the leaking product as it has radioactivity in it. The product has a history of leaking in our department, ct and the er. I am told the company representative will be on site next week in the er. The staff was instructed to tighten the hubs and that has not resolved the situation. I believe the pressure from the injection is either backing of the tightness of the hub or just leaking around it. Five days later: per the baxter sales rep. , all one link extension sets are rated for 325 p. S. I. The vendor will be meeting with clinical manager today to review this incident.
 
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Brand NameONE-LINK NON-DEHP MICROBORE CATHETER EXTENSION
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
25212 w. illinois route 120
round lake IL 60073
MDR Report Key7032685
MDR Text Key92195825
Report Number7032685
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 10/04/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/15/2017
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7N8300
Device Catalogue Number7N8300
Device Lot Number(10)UR17F-13027
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/04/2017
Event Location Hospital
Date Report to Manufacturer10/04/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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