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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 Crack (1135); Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported (8) micro-volume extension sets were observed cracked which subsequently leaked.It was further reported ¿a couple leaked right out of the package¿.The events 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.
 
Manufacturer Narrative
Additional information was added to h6.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.
 
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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 Key11986704
MDR Text Key256048361
Report Number1416980-2021-03590
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
Report Date 08/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number2N3382
Was Device Available for Evaluation? No
Date Manufacturer Received08/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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