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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD (SUZHOU) INTIMA-II 20GAX1.16IN PRN INTERVASCULAR CATHETER

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BD (SUZHOU) INTIMA-II 20GAX1.16IN PRN INTERVASCULAR CATHETER Back to Search Results
Catalog Number 383057
Device Problem Leak/Splash (1354)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 08/13/2019
Event Type  malfunction  
Manufacturer Narrative
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 defective tubing occurred during use with a intima-ii 20ga x 1. 16 in prn. The following information was provided by the initial reporter, "on the morning of (b)(6) 2019, ct nurse performed venipuncture (20g xiangma) on the patient according to the routine procedure. When the examination was performed, it was found that the contrast agent infusion failed to display image normally due to the indwelling needle extension tube burst during the high-pressure infusion, the drug completely flowed out, and the patient's blood flowed out. This situation caused the patient to be frightened and had a great dissatisfaction. The nurse thought it was caused by improper operation. And give more cautious and care for the next operation for the patient. And not feed back the case to the sales representative. However, in the afternoon, a similar squib situation occurred again in a patient who used 22 g xiangma(product trade name). The flow rate set at the time was 3. 5 ml/s, the pressure was limited to 325 psi, and the burst position was near the junction of the catheter hub and the extension tube. Because it is the second case on the same day, the nurse questioned the quality of the product, and believed that it caused the patient's complaint, the waste of liquid medicine, and the impact of work efficiency. The situation was fed back to the department leaders, and the department leaders was attached great attention to it. Required that all the inventory products should be replaced, the quality of the products should be investigated, and the response should be given as soon as possible. Otherwise they will be worried for using the bd products again. ".
 
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Brand NameINTIMA-II 20GAX1.16IN PRN
Type of DeviceINTERVASCULAR 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 Key8960877
MDR Text Key156904854
Report Number3006948883-2019-00723
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 10/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date05/01/2022
Device Catalogue Number383057
Device Lot Number9077649
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 Received08/13/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/18/2019
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: 09/04/2019 Patient Sequence Number: 1
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