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Adverse Event Report

B. BRAUN MEDICAL, INC. BECTON-DICKINSON 360 INFUSOR SYRINGE PUMP   back to search results
Model Number 2800
Event Date 01/15/2002
Event Type  Malfunction  
Event Description

This device was returned for service repair with an explanation that it had failed speed testing at the user facility. No patient was involved.

 
Manufacturer Narrative

The company could not duplicate the reported device failure during testing. The pump delivered within specifications for both high and low speed testing.

 
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Brand NameBECTON-DICKINSON 360 INFUSOR
Type of DeviceSYRINGE PUMP
Baseline Brand Name360 INFUSER
Baseline Generic NameSYRINGE INFUSION PUMP
Baseline Catalogue Number2800
Baseline Model Number2800
Baseline Device Family360 INFUSER
Baseline Device 510(K) NumberK844719
Baseline Device PMA Number
Baseline Shelf Life Information No
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed01/28/1985
Manufacturer (Section F)
B. BRAUN MEDICAL, INC.
1601 wallace dr., suite 150
carrollton TX 75006 6690
Manufacturer (Section D)
B. BRAUN MEDICAL, INC.
1601 wallace dr., suite 150
carrollton TX 75006 6690
Manufacturer Contact
ruth kummerlen manager
1601 wallace dr. ste. 150
carrollton , TX 75006
(972) 245 -2243
Device Event Key366314
MDR Report Key377234
Event Key356002
Report Number1641965-2002-00002
Device Sequence Number1
Product CodeFRN
Report Source Manufacturer
Source Type Consumer,User facility
Reporter Occupation Other
Remedial Action Inspection
Type of Report Initial
Report Date 02/11/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/12/2002
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Other
Device MODEL Number2800
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/18/2002
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/18/2002
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/01/1998
Is The Device Single Use? No
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided
Type of Device Usage Reuse

Database last updated on February 28, 2009

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