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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON BD SAF-T-INTIMA; IV CATHETER
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BECTON DICKINSON BD SAF-T-INTIMA; IV CATHETER Back to Search Results
Catalog Number 383323
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inflammation (1932); Irritation (1941)
Event Date 01/01/2012
Event Type  Injury  
Event Description
On (b)(6) 2014, the reporter stated that after a 72 hours of infusion in subcutaneous, lymphangitis with hyperthermia the pt experienced irritation and inflammation.On an unk date, the infusion was discontinued and antibiotics were administered.Attempt was made to obtain more info but were unsuccessful.No further info is available.
 
Manufacturer Narrative
No product return is anticipated.Dhr was conducted and no anomalies noted.Quality will continue to monitor on monthly trend.
 
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Brand Name
BD SAF-T-INTIMA
Type of Device
IV CATHETER
Manufacturer (Section D)
BECTON DICKINSON
1 becton dr.
franklin lakes NJ 07417 188
Manufacturer (Section G)
BECTON DICKINSON - INFUSION THERAPY SYSTEMS
blvd luis donaldo colosio #3100
nogales, sonora
MX  
Manufacturer Contact
elizabeth closner, rn, bsn
1 becton dr.
franklin lakes, NJ 07417
2105265165
MDR Report Key3743239
MDR Text Key15176318
Report Number2243072-2014-00053
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 03/21/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number383323
Device Lot Number2060137
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/25/2014
Initial Date FDA Received03/24/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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