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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 383033
Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/20/2020
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. (b)(4).
 
Event Description
It was reported that the bd intima-ii closed iv catheter system experienced a loose needle which was noted prior to use. The following information was provided by the initial reporter: children admitted because of "upper respiratory infection", after admission examination double lung breath sounds crude, the doctor's advice to cool the anti-inflammatory drugs such as symptomatic treatment, prescribed given intravenous infusion, to reduce children with piercing pain for many times, the family agreed to give needle injection, operation found needle core is loose, not operation, change in time, did not have a negative effect. For in what way is the needle loose: it is the needle deflecting during attempted puncture.
 
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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 Key10314403
MDR Text Key202023328
Report Number3006948883-2020-00310
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date06/25/2022
Device Catalogue Number383033
Device Lot Number9141723
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 Received07/03/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/21/2019
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: 07/23/2020 Patient Sequence Number: 1
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