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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 383005
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/09/2020
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.Fda device problem code:(b)(4).Fda patient problem code: (b)(4).
 
Event Description
It was reported that the bd intima-ii¿ closed iv catheter system leaked during use.The following information was provided by the initial reporter, translated from chinese to english: "on 10-9 after successful puncture with indwentric needle, the leakage on the side of the indwentric needle heparin cap was found and replaced immediately".
 
Event Description
It was reported that the bd intima-ii¿ closed iv catheter system leaked during use.The following information was provided by the initial reporter, translated from chinese to english: "on 10-9 after successful puncture with indwentric needle, the leakage on the side of the indwentric needle heparin cap was found and replaced immediately.".
 
Manufacturer Narrative
H.6.Investigation: there was no sample or photo available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.Since, an investigation could not be performed bd was unable to determine a possible root cause.A review of the device history record was performed and no quality issues were found during production.
 
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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
MDR Report Key11103234
MDR Text Key225796192
Report Number3006948883-2020-01078
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 02/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date12/06/2022
Device Catalogue Number383005
Device Lot Number9298551
Was Device Available for Evaluation? No
Date Manufacturer Received02/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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