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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 383078
Device Problem Leak/Splash (1354)
Patient Problem Blood Loss (2597)
Event Date 06/09/2019
Event Type  malfunction  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that bd intima-ii¿ closed iv catheter system leaked during use.The following information was provided by the initial reporter: it was found infusion device occluded, then checked the intima-ii then found blood leakage at prn, nurse tried to tighten the prn, blood still leaked.
 
Event Description
It was reported that bd intima-ii¿ closed iv catheter system leaked during use.The following information was provided by the initial reporter: it was found infusion device occluded, then checked the intima-ii then found blood leakage at prn, nurse tried to tighten the prn, blood still leaked.
 
Manufacturer Narrative
H.6.Investigation summary: a device history review was conducted for lot number 8305836.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 was submitted for evaluation and testing.No abnormalities could be identified in the returned sample despite attempts to identify the cause using leakage testing and microscopic evaluation of the device.A possible explanation for this phenomena is the sterilization process of all potentially contaminated devices.The high heat of this process is sufficient to result in the deformation of the septum, potentially sealing any openings that would allow the passage of fluid.H3 other text : see section h.10.
 
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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 Key8728576
MDR Text Key149187268
Report Number3006948883-2019-00490
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
N/A
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 07/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date11/12/2021
Device Catalogue Number383078
Device Lot Number8305836
Date Manufacturer Received06/09/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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