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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 383012
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/30/2021
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 when using the bd intima ii¿ iv catheter prn adapter there was leakage.The following information was provided by the initial reporter.The customer stated: "contrast extravasation was found during the enhanced ct examination of the patient the examination of the patient was immediately stopped when contrast extravasation was found at the heparin cap.After replacing the indwelling needle, the examination of the patient was continued without contrast extravasation, and no other adverse effects were caused to the patient.".
 
Manufacturer Narrative
H6: investigation: 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.Additionally communication with the facility allowed our engineers to determine that the adaptor was not adequately tightened prior to use.Based on this information our engineers have determined that he root cause for this event was likely a combination of the use of high pressure injection through an infusion-only device and a loose adaptor.
 
Event Description
It was reported when using the bd intima ii¿ iv catheter prn adapter there was leakage.The following information was provided by the initial reporter.The customer stated: "contrast extravasation was found during the enhanced ct examination of the patient the examination of the patient was immediately stopped when contrast extravasation was found at the heparin cap.After replacing the indwelling needle, the examination of the patient was continued without contrast extravasation, and no other adverse effects were caused to the patient.".
 
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Brand Name
BD INTIMA II¿ IV CATHETER PRN ADAPTER
Type of Device
INTRAVASCULAR 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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key13122215
MDR Text Key286592344
Report Number3014704491-2021-00404
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 01/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date11/09/2022
Device Catalogue Number383012
Device Lot Number9298397
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/03/2021
Initial Date FDA Received12/30/2021
Supplement Dates Manufacturer Received01/03/2022
Supplement Dates FDA Received01/11/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/25/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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