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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - IRVINE INFUSOR; PUMP, INFUSION, ELASTOMERIC
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BAXTER HEALTHCARE - IRVINE INFUSOR; PUMP, INFUSION, ELASTOMERIC Back to Search Results
Catalog Number J2C1711
Device Problem Scratched Material (3020)
Patient Problem No Patient Involvement (2645)
Event Date 01/08/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device was received and is currently awaiting evaluation.Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that there were scratches on the housing of a small volume infusor.This was noted after filling.There was no patient involvement.No additional information is available.
 
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Brand Name
INFUSOR
Type of Device
PUMP, INFUSION, ELASTOMERIC
Manufacturer (Section D)
BAXTER HEALTHCARE - IRVINE
17511 armstrong avenue
bldg 3
irvine CA 92614
Manufacturer (Section G)
BAXTER HEALTHCARE - IRVINE
17511 armstrong avenue
bldg 3
irvine CA 92614
Manufacturer Contact
kinga almasan
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key5394255
MDR Text Key36927020
Report Number1416980-2016-02003
Device Sequence Number1
Product Code MEB
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 01/27/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberJ2C1711
Device Lot Number15H040
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/25/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/12/2016
Was Device Evaluated by Manufacturer? No
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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