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U.S. Department of Health and Human Services

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

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BD (SUZHOU) BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383028
Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 12/05/2019
Event Type  Injury  
Manufacturer Narrative
Initial reporter phone #: unknown. 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 the patient left hospital with catheter still inserted, family members attempted to remove but catheter broke off in vein with a bd intima-ii¿ closed iv catheter system. The following information was provided by the initial reporter, translated from (b)(6) to english: during the hospitalization, on december 4, it was unclear whether the patient had sought the consent of the medical staff or the doctor on duty. After the treatment, the patient left the hospital and went home by himself. At around 9:00 a. M. On december 5, the patient's family pulled out the indwelling needle at home by themselves and found that the catheter part of the front end of the isolation plug of the indwelling needle was indwelling in the patient's body. After the occurrence of problems, the patient's guardian found the head nurse and conducted b-ultrasound examination in the hospital. The b-ultrasound location found that the broken tube was 1. 8cm away from the puncturing point, suggesting surgical removal during this process, the sales rep had reminded the head nurse that the patient was not recommended to move the patient during this period because of the catheter drifting with the blood. The head nurse also informed the patient's family of the possible risks according to this reminder. It was not clear whether the product in question had been reserved or not, and it was not possible to confirm whether the sample had been returned.
 
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Brand NameBD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
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 Key9505609
MDR Text Key182211815
Report Number3006948883-2019-01115
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 01/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date06/16/2022
Device Catalogue Number383028
Device Lot Number9141710
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 Received12/05/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/21/2019
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: 12/20/2019 Patient Sequence Number: 1
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