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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. BD¿ INTIMA-II Y 24GAX0.75IN PRN/EC SLM INTERVASCULAR CATHETER

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BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. BD¿ INTIMA-II Y 24GAX0.75IN PRN/EC SLM INTERVASCULAR CATHETER Back to Search Results
Catalog Number 383033
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Arrhythmia (1721); Erythema (1840); High Blood Pressure/ Hypertension (1908); Swelling (2091); Reaction (2414); Constipation (3274)
Event Date 12/31/2019
Event Type  Injury  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
 
Event Description
It has been reported that one bd¿ intima-ii y 24gax0. 75in prn/ec slm has been found causing an allergic reaction during use. The following has been provided by the initial reporter: on (b)(6) 2019, the patient was admitted to the hospital due to "decreased gastric absorption for one month and constipation for 10 days", and the admission was diagnosed as " lack of appetite (cause); hypertension level 3 (very high risk); arrhythmia (frequent premature ventricular beats); constipation (check for cause); lumbar spondylolisthesis ". At 14:55 on (b)(6), the nurse found that there was redness and swelling at the puncture site of the infusion on the right side of the patient's head, and the swelling range was about 10*9cm. It was found that the infusion liquid was fatty milk, and about 50ml had been injected. The patient did not report pain, and there was no redness around the puncture site. 0. 9% sodium chloride injection and 100ml+ dexamethasone 10mg was applied to wet compress the head, and the head of the bed was raised 60°. Skin swellness of the patient was closely observed.
 
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Brand NameBD¿ INTIMA-II Y 24GAX0.75IN PRN/EC SLM
Type of DeviceINTERVASCULAR CATHETER
Manufacturer (Section D)
BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
9 rui pu road export zone b
suzhou
Manufacturer (Section G)
BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
9 rui pu road export zone b
suzhou
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key9643705
MDR Text Key182220859
Report Number3006948883-2020-00036
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 02/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number383033
Device Lot Number9106918
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 Received01/09/2020
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: 01/29/2020 Patient Sequence Number: 1
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