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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. BD SAF-T-INTIMA¿ CLOSED IV CATHETER SYSTEM

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BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. BD SAF-T-INTIMA¿ CLOSED IV CATHETER SYSTEM Back to Search Results
Catalog Number 383005
Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Patient Problems Abdominal Pain (1685); Perforation (2001)
Event Date 12/10/2019
Event Type  malfunction  
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 saf-t-intima¿ closed iv catheter system has been found with a damaged catheter before use. The following has been provided by the initial reporter: in order to seek further diagnosis and treatment in our hospital, the outpatient department underwent plain standing radiographs and admitted to our department with "1, gastric perforation 2, and abdominal pain check factor". Since the onset, the spirit and diet have been poor, the stool has not been resolved, and the weight has not changed significantly. Body temperature is 36. 9, pulse is 82 beats / min, breath is 20 beats / min, blood pressure is 111 / 78mmhg. The closed indwelling needle was used before the operation, and the needle catheter was found to be bifurcated. The indwelling needle was immediately replaced with a new one, and the patient's condition continued to be observed. This event did not affect the patient's physical and mental health, and there was no combined use of this event.
 
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Brand NameBD SAF-T-INTIMA¿ CLOSED IV CATHETER SYSTEM
Type of DeviceCATHETER
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 Key9540538
MDR Text Key181442824
Report Number3006948883-2019-01159
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 02/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number383005
Device Lot Number8326608
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 Received12/17/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/22/2018
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: 01/02/2020 Patient Sequence Number: 1
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