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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 Problem Fluid Leak (1250)
Patient Problems Phlebitis (2004); Vomiting (2144); Loss of consciousness (2418)
Event Date 12/03/2019
Event Type  Injury  
Manufacturer Narrative
Initial reporter phone #: unknown. 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 patient was diagnosed with phlebitis after a bd intima-ii¿ closed iv catheter system was used. The following information was provided by the initial reporter, translated from (b)(6) to english: on (b)(6) 2019, the patient was "found unconscious for about 1 hour, vomited twice and was admitted to hospital, diagnosed as" 1. 2. Obstructive hydrocephalus; 3. The focal cerebral ischemia (bilateral radial multiple focal ischemia) ", to act well drilling bilateral lateral ventricle puncture drainage, pipe outside left elbow lien 24 patients with closed venous indwelling needle, preoperative, intraoperative on the left side of the needle sodium acetate saline infusion fluids, did not see to the obvious swelling, turn postoperative intensive medicine ward, it found that the left elbow leakage of liquids, measuring the left upper arm 33 cm, lower arm 27 cm; right upper arm 31cm, lower arm 24cm. Treatment: extract about 10ml of the liquid and remove the indwelling needle. Raise the affected limb and continue to observe the condition of infusion limb.
 
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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 Key9510762
MDR Text Key182211882
Report Number3006948883-2019-01120
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 02/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number383033
Device Lot Number9106902
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 Received12/06/2019
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: 12/23/2019 Patient Sequence Number: 1
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