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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU BD INTIMA II IV CATHETER PRN ADAPTER INTRAVASCULAR CATHETER

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BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU BD INTIMA II IV CATHETER PRN ADAPTER INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383019
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/29/2021
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: in response to the event reported, a device history review was conducted for lot number 9050858. Our records show that this is the only instance of this issue occurring in this production batch. 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. A sample could not be obtained for evaluation and testing; in lieu of the affected device, functional testing was performed on retention samples for this lot, the results of these show that the tested units performed within product specifications. 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 bd intima ii¿ iv catheter prn adapter was damaged during the high-pressure contrast injection. The following information was provided by the initial reporter, translated from (b)(6) to english: "on (b)(6) 2021, the patient went to the radiology department for enhanced ct examination of the whole abdomen. When the nurse injected drugs, the high-pressure syringe reported an emergency error. The nurse immediately suspended infusion and checked the patient's condition. After checking, the nurse found that the indwelling needle was damaged. Contrast agent was injected with a high-pressure syringe without any other medical device combination. " "it is a high frequency injection, but the specific pressure value is now uncertain. ".
 
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Brand NameBD INTIMA II IV CATHETER PRN ADAPTER
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
no.1 liangpu street
suzhou industrial park
suzhou 21512 6
CH 215126
Manufacturer (Section G)
BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
no.1 liangpu street
suzhou industrial park
suzhou 21512 6
CH 215126
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12586844
MDR Text Key283595175
Report Number3014704491-2021-00184
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 foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number383019
Device Lot Number1051539
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 Received09/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/20/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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