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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD (SUZHOU) BD INTIMA II¿ IV CATHETER INTRAVASCULAR CATHETER

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BD (SUZHOU) BD INTIMA II¿ IV CATHETER INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383407
Device Problem Insufficient Information (3190)
Patient Problems Fever (1858); Inflammation (1932)
Event Date 07/12/2017
Event Type  Injury  
Manufacturer Narrative
Results: the customer returned two samples, the samples were of both a 24g and 22g bd intima ii¿ iv catheter. Neither sample had been used and there was no evidence of any abnormalities. Both the test of bi aseptic and the eo residue test passed with no errors noted. Conclusion: bd was not able to duplicate or confirm the customer¿s indicated failure mode and an absolute root cause for this incident cannot be determined.
 
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used. 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 nurse found 10 cases of phlebitis after using a bd intima ii¿ iv catheter (22g and 24g). The patient had a fever initially but after removal of the iv, fever was resolved and no additional treatment was needed.
 
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Brand NameBD INTIMA II¿ IV CATHETER
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
8015652845
MDR Report Key6759193
MDR Text Key109941622
Report Number3006948883-2017-00031
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K143610
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/01/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2019
Device Catalogue Number383407
Device Lot Number6018383
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 Received07/12/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/18/2016
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: 08/01/2017 Patient Sequence Number: 1
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