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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD (SUZHOU) BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER

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BD (SUZHOU) BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383028
Device Problem Leak/Splash (1354)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 05/22/2019
Event Type  malfunction  
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 during use of the bd intima-ii¿ closed iv catheter system the heparin cap of the intravenous indwelling needle continued to bleed. The nurse immediately replaced the heparin cap and continued blood collection and infusion. Foreign complaint the following information was provided by the initial reporter, translated from (b)(6) to english: it was found bleeding at prn, then changed the prn.
 
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Brand NameBD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
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
8015652341
MDR Report Key8693733
MDR Text Key147907183
Report Number3006948883-2019-00460
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
N/A
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
Report Date 07/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/20/2021
Device Catalogue Number383028
Device Lot Number8325642
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/23/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/21/2018
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: 06/12/2019 Patient Sequence Number: 1
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