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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 Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Patient Problem Pneumonia (2011)
Event Date 10/28/2019
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 leakage occurred during use with a bd intima-ii¿ closed iv catheter system. The following information was provided by the initial reporter ((b)(6) translation), "the patient who was cough with no obvious reason since a half months ago, and he had gustiness bother cough with larynx phlegm, nasal congestion, and barking cough. The sign of cough was not crowing at the end of the echo, there was no short of breath, wheezing, no fever, headache, vomiting, fatigue, night sweats, and no rash. On (b)(6) 2019 the child came to our clinics, he had taken the chest is a piece of both lungs texture densification, both lungs howed a little light shadow, sharp on both sides of the rib diaphragmatic angle, heart shadow had no abnormal sign. Considering mycopneumonia, the patient was admitted to the one-step outpatient department for "bronchial pneumonia". Closed intravenous indwelling needle was used for infusion at 10:05 am, (b)(6) 2019. After completion, no abnormal usage was found. On (b)(6) 2019 at 0:10, the nurse was ready to give patients injections, she was goning to open the clamp to use disposable syringes 2 ml to withdraw of indwelling needle, it was unusual to take more air from the needle, then the nurse pulled out the indwelling needle immediately, gave patients stop bleeding action. After the bleeding was stopped, they used the new closed venous indwelling needle for puncturing. There was no sign of abnormal after the doctor's observing. A small amount of water was added to the sealed the needle in a disposable dispenser and air is injected with a disposable syringe, there was the bubble at the 3cm to the tip of the needle. ".
 
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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 Key9377209
MDR Text Key180207633
Report Number3006948883-2019-00982
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,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number383028
Device Lot Number9106906
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 Received11/08/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/16/2019
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: 11/26/2019 Patient Sequence Number: 1
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