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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - CALI ACCESS; STOPCOCK, I.V. SET
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BAXTER HEALTHCARE - CALI ACCESS; STOPCOCK, I.V. SET Back to Search Results
Catalog Number ARC2220P
Device Problem Partial Blockage (1065)
Patient Problem No Patient Involvement (2645)
Event Date 06/01/2015
Event Type  malfunction  
Event Description
It was reported that the three way clamp on an access set presented a blockage during priming.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
(b)(4).A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; 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
ACCESS
Type of Device
STOPCOCK, I.V. SET
Manufacturer (Section D)
BAXTER HEALTHCARE - CALI
apartado aereo 2446
calle #36
cali
CO 
Manufacturer (Section G)
BAXTER HEALTHCARE - CALI
apartado aereo 2446
calle #36
cali
CO  
Manufacturer Contact
kinga almasan
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key4866231
MDR Text Key5867034
Report Number1416980-2015-26512
Device Sequence Number1
Product Code FMG
Combination Product (y/n)N
Reporter Country CodeCO
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 06/01/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/31/2017
Device Catalogue NumberARC2220P
Device Lot NumberSE14LD7
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/01/2015
Initial Date FDA Received06/24/2015
Date Device Manufactured12/03/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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