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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM INTRAVASCULAR CATHETER

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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383328
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Edema (1820); Pain (1994)
Event Date 12/12/2017
Event Type  Injury  
Manufacturer Narrative
Investigation results: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this occurrence. A review of the device history records and the microbiological tests (pyrogens) in the certificate of sterility, all the units (b)(4) meet with acceptance criteria. Testing revealed no irregularities during the manufacture and sterilization of reported lot number 7115948. Without sample or photo we could not confirm or associate the reported defect to manufacturing process. We could not find a definitive root cause, since no sample or photo was returned for evaluation. No capa was opened since this issue could not be confirmed as manufacturing related.
 
Manufacturer Narrative
(b)(4). A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that the diabetic patient received the bd saf-t-intima¿ iv catheter safety system. The next day the patient reported pain and edema was identified as erysipelas. No other action or medical intervention was noted.
 
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Brand NameBD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
Manufacturer (Section G)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key7183111
MDR Text Key254427293
Report Number9610847-2017-00241
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K923702
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 02/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Expiration Date04/30/2021
Device Catalogue Number383328
Device Lot Number7115948
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/18/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/31/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/11/2018 Patient Sequence Number: 1
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