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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION EXTENSION SETS WITH ONE-LINK NEEDLE-FREE LV CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 7N8370K
Device Problem Disconnection (1171)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that there was a separation at the distal end above the male luer of a one-link non-dehp y-type microbore catheter extension set. This occurred during an unspecified process step. There was no report of patient injury or medical intervention associated with this event. No additional information is available.
 
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Brand NameEXTENSION SETS WITH ONE-LINK NEEDLE-FREE LV CONNECTOR
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
BAXTER HEALTHCARE - DOMINICAN REPUBLIC
carretera sanchez km 18.5
parque industrial itabo, piisa
haina san cristobal
DR
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key11089576
MDR Text Key224757438
Report Number1416980-2020-08159
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number7N8370K
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 Received01/27/2021
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 Initial

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