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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION INTRAVASCULAR EXTENSION SETS AND ACCESSORIES; FILTER, INFUSION LINE
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BAXTER HEALTHCARE CORPORATION INTRAVASCULAR EXTENSION SETS AND ACCESSORIES; FILTER, INFUSION LINE Back to Search Results
Catalog Number 2N3382
Device Problems Backflow (1064); Crack (1135); Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/16/2021
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported a micro-volume extension set was observed cracked and subsequently leaked from an unknown location.Blood was observed blood backing up in the tubing.There was no patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
H10: 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.
 
Manufacturer Narrative
Correction: b4/f8: date of this report in the initial mdr is being corrected from blank to 04/21/2021.
 
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Brand Name
INTRAVASCULAR EXTENSION SETS AND ACCESSORIES
Type of Device
FILTER, INFUSION LINE
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key11701320
MDR Text Key248589940
Report Number1416980-2021-02286
Device Sequence Number1
Product Code FPB
Combination Product (y/n)Y
PMA/PMN Number
K192366
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 07/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number2N3382
Device Lot NumberASKU
Was Device Available for Evaluation? No
Date Manufacturer Received07/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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