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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 383083
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Erythema (1840)
Event Date 03/29/2023
Event Type  Injury  
Event Description
It was reported that the patient experienced adverse event without identified device problem while using bd intima-ii iv catheter.The following information was provided by the initial reporter: after 3 days of use, the puncture point of the patient's indwelling needle was found to be red and swollen.Received an update from the sales representative, and the description of the incident was updated as follows: after 3 days of use, it was found that the puncture point of the indwelling needle was red and swollen.It has been communicated with the clinic that the patient is a child and the disease is mycoplasma pneumonia, which may be caused by the long indwelling days, the easy movement of the child, and the infusion of irritating fluids.
 
Manufacturer Narrative
H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
H6: investigation summary: a device history review was conducted for lot number 2110919.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Additionally, a sample could not be obtained for evaluation and testing, but this lot was treated and received a certificate of conformance for sterility.Unfortunately, without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.
 
Event Description
It was reported that the patient experienced adverse event without identified device problem while using bd intima-ii iv catheter.The following information was provided by the initial reporter: after 3 days of use, the puncture point of the patient's indwelling needle was found to be red and swollen.Received an update from the sales representative, and the description of the incident was updated as follows: after 3 days of use, it was found that the puncture point of the indwelling needle was red and swollen.It has been communicated with the clinic that the patient is a child and the disease is mycoplasma pneumonia, which may be caused by the long indwelling days, the easy movement of the child, and the infusion of irritating fluids.
 
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Brand Name
BD INTIMA-II IV CATHETER
Type of Device
INTRAVASCULAR 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
phillip emmert
5859 farinon drive
san antonio, TX 78249
8448235433
MDR Report Key16782359
MDR Text Key313709264
Report Number3014704491-2023-00135
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/24/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Catalogue Number383083
Device Lot Number2110919
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/31/2023
Initial Date FDA Received04/20/2023
Supplement Dates Manufacturer Received04/24/2023
Supplement Dates FDA Received05/09/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/20/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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