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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 Delivered as Unsterile Product (1421)
Patient Problem No Patient Involvement (2645)
Event Date 09/15/2020
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 needle had no cap on it and was contaminated. The following information was provided by the initial reporter, translated from (b)(6) to english: the patient was admitted to hospital on (b)(6) 2020. On (b)(6) the patient was treated with a closed intravenous indwser as prescribed by the doctor. Nurse carried the closed intravenous indwser needle to the bedside and found that the indwser needle had no cap and the needle was contaminated. Immediately explain to the patient and replace the new closed intravenous indwelling needle for the treatment of the patient. This incident delays the treatment of the patient and increases the medical cost. There is no device combination in this event.
 
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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
8015296192
MDR Report Key10796134
MDR Text Key220716386
Report Number3006948883-2020-00710
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 12/04/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number383028
Device Lot Number9262096
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 Received12/04/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/19/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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