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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 7N8300
Device Problem Filling Problem (1233)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Date of event: date is unknown.(b)(4).Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported a one-link non-dehp microbore catheter extension set under infused when used in conjunction with a clearlink system continu-flo solution set.It was further reported, the ¿medication didn¿t administer in the appropriate time frame¿.The medication being infused was oxaliplatin.There was no patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
Additional information: h6 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
EXTENSION SETS WITH ONE-LINK NEEDLE-FREE LV CONNECTOR
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key10264798
MDR Text Key198569569
Report Number1416980-2020-03950
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
Report Date 08/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number7N8300
Device Lot NumberASKU
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/16/2020
Initial Date FDA Received07/13/2020
Supplement Dates Manufacturer Received08/12/2020
Supplement Dates FDA Received08/13/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET; OXALIPLATIN; CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET; OXALIPLATIN
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