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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 CATHETE

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BD (SUZHOU) BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETE Back to Search Results
Catalog Number 383083
Device Problem Material Perforation (2205)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 10/31/2022
Event Type  malfunction  
Event Description
It was reported that the bd intima-ii¿ closed iv catheter system experienced the following information was provided by the initial reporter: the patient was given intravenous indwelling needle puncture for infusion therapy.The core of the indwelling needle did not match the hose (the core of the steel needle broke through the hose and the hose was not fed smoothly), resulting in children with ruptured blood vessels, the puncture was unsuccessful, to be re-punctured, and explain the communication work to the parents.
 
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 the bd intima-ii¿ closed iv catheter system needle broke through the hose during use.The following information was provided by the initial reporter: the patient was given intravenous indwelling needle puncture for infusion therapy.The core of the indwelling needle did not match the hose (the core of the steel needle broke through the hose and the hose was not fed smoothly), resulting in children with ruptured blood vessels, the puncture was unsuccessful, to be re-punctured, and explain the communication work to the parents.
 
Manufacturer Narrative
The following field was updated due to corrections: b.5.Describe event or problem: it was reported that the bd intima-ii¿ closed iv catheter system needle broke through the hose during use.H.6.Investigation summary: in response to the event reported, a device history review was conducted for lot number 2110919.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.Bd will continue to monitor this issue.
 
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Brand Name
BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
Type of Device
INTRAVASCULAR CATHETE
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
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key15921582
MDR Text Key305820650
Report Number3014704491-2022-00635
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 12/11/2022
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 Catalogue Number383083
Device Lot Number2110919
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/11/2022
Initial Date FDA Received12/05/2022
Supplement Dates Manufacturer Received12/11/2022
Supplement Dates FDA Received12/29/2022
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
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