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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - AIBONITO EXTENSION SETS WITH ONE-LINK NEEDLE-FREE LV CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR

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BAXTER HEALTHCARE - AIBONITO EXTENSION SETS WITH ONE-LINK NEEDLE-FREE LV CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 7N8301
Device Problem Cut In Material (2454)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/03/2018
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported the tubing of a one-link catheter extension set was splitting when attached to the patient¿s catheter. This event occurred during patient infusion. There was no patient injury or medical intervention associated with this event. No additional information is available.
 
Manufacturer Narrative
A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. The device was not returned; 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 NameEXTENSION SETS WITH ONE-LINK NEEDLE-FREE LV CONNECTOR
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 Key7470337
MDR Text Key106837570
Report Number1416980-2018-02429
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,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number7N8301
Device Lot NumberUR18A17036
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 Received05/10/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/18/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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