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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - TIJUANA BAJA CARTRIDGE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
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BAXTER HEALTHCARE - TIJUANA BAJA CARTRIDGE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE Back to Search Results
Catalog Number 103401
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/27/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Should additional information become available a supplemental report will be submitted.
 
Event Description
It was reported that during patient treatment with a cartridge bloodline, an external blood leak was observed at the level of the venous line.The amount of blood was not reported.There was no patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
The actual device was available for evaluation and evaluated by baxter.A leak test was performed identifying an external leakage at the level of the venous injection port caused by a white rubber plug that was not properly inserted.The reported condition was verified.The cause of the condition was determined to be a manufacturing issue.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
CARTRIDGE
Type of Device
SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
Manufacturer (Section D)
BAXTER HEALTHCARE - TIJUANA BAJA
tijuana baja california
MDR Report Key7991588
MDR Text Key126115058
Report Number8030638-2018-00023
Device Sequence Number1
Product Code FJK
Combination Product (y/n)N
PMA/PMN Number
K070414
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 11/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number103401
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/16/2018
Date Manufacturer Received11/13/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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