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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 383083
Device Problems Contamination (1120); Crack (1135)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/15/2022
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: in response to the event reported by the facility a device history review was conducted for lot number 2011052.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.
 
Event Description
It was reported that bd intima-ii¿ closed iv catheter system experienced 2 cases of catheter hub damage, and an unspecified number of cases of foreign matter on the device catheter.The following information was provided by the initial reporter: the head nurse of cardiovascular medicine reported that the surface was uneven with small white spots when the product was opened.
 
Event Description
It was reported that bd intima-ii¿ closed iv catheter system experienced 2 cases of catheter hub damage, and an unspecified number of cases of foreign matter on the device catheter.The following information was provided by the initial reporter: the head nurse of cardiovascular medicine reported that the surface was uneven with small white spots when the product was opened.
 
Manufacturer Narrative
H6: investigation summary a device history review was conducted for lot number 2011052.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.
 
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Brand Name
BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
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
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key15637131
MDR Text Key306515503
Report Number3014704491-2022-00499
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 10/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number383083
Device Lot Number2011052
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/24/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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