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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD (SUZHOU) BD INTIMA II¿ IV CATHETER 24G X 0.75 INTRAVASCULAR CATHETER

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BD (SUZHOU) BD INTIMA II¿ IV CATHETER 24G X 0.75 INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383408
Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/13/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that on the second day of infusion, the patient removed the suspect device from the back of the hand in the middle of the night. The nurse found the catheter broken after two hours. The patient had a ct scan of the arm but the brother catheter was not detected.
 
Manufacturer Narrative
Additional information added as follows: sex - female. Describe event or problem - this incident occurred in the department of neurology. The patient had suffered a stroke and was delirious. Blood was noted inside of the extension catheter after removal but the patient is not known to have an infectious disease. The patient has since been discharged from the hospital. Device evaluation: result - one actual used sample was returned for evaluation. A visual examination of the sample was performed and found the catheter was broken from the root of the catheter. This section of catheter was noted to have stretch marks. A review of the device history record revealed no abnormalities during the manufacture of the reported lot number 6134279. This device was manufactured in july 2016. Conclusion - bd was able to confirm the customer's indicated failure mode. The returned sample broken catheter cross section has a tensile deformation. According to complaint information, the patient pulled out the device. Therefore, the probable root cause of this defect is patient stretching the device.
 
Event Description
This incident occurred in the department of neurology. The patient had suffered a stroke and was delirious. Blood was noted inside of the extension catheter after removal but the patient is not known to have an infectious disease. The patient has since been discharged from the hospital.
 
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Brand NameBD INTIMA II¿ IV CATHETER 24G X 0.75
Type of DeviceINTRAVASCULAR 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
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key6228403
MDR Text Key64034219
Report Number3006948883-2017-00001
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K143610
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2019
Device Catalogue Number383408
Device Lot Number6134279
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/13/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/13/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 01/06/2017 Patient Sequence Number: 1
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