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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 Problem Crack (1135)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/26/2021
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported a crack was observed a on the collar of a micro-volume extension set.The event occurred while the user was ¿disconnecting and reconnecting¿ to a patient¿s line.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
Correction: this report is a duplicate of manufacturer report number1416980-2021-02424.All information can be found under manufacturer report number 1416980-2021-02424.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 Key11776171
MDR Text Key249042181
Report Number1416980-2021-02656
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 06/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/05/2021
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 Received05/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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