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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD (SUZHOU) BD INTIMA II¿ IV CATHETER PRN ADAPTER INTRAVASCULAR CATHETER

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BD (SUZHOU) BD INTIMA II¿ IV CATHETER PRN ADAPTER INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383019
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Phlebitis (2004)
Event Date 04/04/2018
Event Type  Injury  
Manufacturer Narrative
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 bd intima ii¿ iv catheter prn adapter caused phlebitis. Furthermore it was reported that "the patient entered into hospital against anti-infection treatment. ".
 
Manufacturer Narrative
Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields. This supplemental emdr is filed to provide the following omitted fields: event attributed to: required intervention. Device single use? no. Device returned to manufacturer: no.
 
Event Description
It was reported that bd intima ii¿ iv catheter prn adapter caused phlebitis. Furthermore it was reported that "the patient entered into hospital against anti-infection treatment. ".
 
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Brand NameBD INTIMA II¿ IV CATHETER PRN ADAPTER
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BD (SUZHOU)
no. 5 baiyu road
suzhou industrial park
suzhou
Manufacturer (Section G)
BD (SUZHOU)
no. 5 baiyu road
suzhou industrial park
suzhou
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key7698742
MDR Text Key114329001
Report Number3006948883-2018-00115
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K143610
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date10/18/2020
Device Catalogue Number383019
Device Lot Number7265037
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 Received06/26/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/22/2017
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: 07/18/2018 Patient Sequence Number: 1
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