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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CARTRIDGE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
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BAXTER HEALTHCARE CORPORATION CARTRIDGE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE Back to Search Results
Catalog Number 103401
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Patient Involvement (2645)
Event Date 05/11/2020
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that an unknown foreign substance was found floating inside the blood lines of a gambro cartridge set during priming.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
The actual device and a picture were received for evaluation.During visual inspection of the actual sample, a cloth fiber particle (further described as "fluff") was identified inside the filter of the venous chamber.The reported condition was verified.The cause was manufacturing related.The picture was visually inspected and the reported condition was not verified.A nonconformance has been opened to address this issue.The lot number was unknown; therefore, a batch review could not be performed.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 CORPORATION
deerfield IL
MDR Report Key10108958
MDR Text Key193315336
Report Number8030638-2020-00007
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 07/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/02/2020
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 Manufacturer06/12/2020
Date Manufacturer Received07/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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