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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD (SUZHOU) BD INTIMA-II¿ 22GAX1.00IN PRN SLM NPVC INTRAVASCULAR CATHETER

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BD (SUZHOU) BD INTIMA-II¿ 22GAX1.00IN PRN SLM NPVC INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383064
Device Problem Infusion or Flow Problem (2964)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/16/2019
Event Type  malfunction  
Manufacturer Narrative
Initial reporter phone #: unknown. A sample is available for evaluation. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that tubing expanded with a bd intima-ii¿ 22gax1. 00in prn slm npvc. The following information was provided by the initial reporter, translated from (b)(6) to english: it was found tube is bulging and nearly bursting, which causes the alarm of the instrument and the termination of enhanced scanning. Represents a supplementary drip rate of 3. 0, < 300 psi.
 
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Brand NameBD INTIMA-II¿ 22GAX1.00IN PRN SLM NPVC
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 Key8658552
MDR Text Key149218089
Report Number3006948883-2019-00422
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,health professional,o
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/31/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date03/08/2022
Device Catalogue Number383064
Device Lot Number9023802
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/27/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/16/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/23/2019
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: 05/31/2019 Patient Sequence Number: 1
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