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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 24 G X 0.75 IN. INTRAVASCULAR CATHETER

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BD (SUZHOU) BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM 24 G X 0.75 IN. INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383408
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Code Available (3191)
Event Date 04/21/2017
Event Type  Injury  
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. (b)(4).
 
Event Description
It was reported that a bd intima-ii¿ closed iv catheter system 24 g x 0. 75 in. Broke off in a patient as a nurse removed it. The patient had a surgical procedure to remove the broken catheter.
 
Manufacturer Narrative
Results: one used sample was returned for evaluation. A visual inspection revealed that the catheter had broken at approximately 1cm from the catheter hub. A microscopic inspection revealed a 1mm crack and a v-shaped cut on the surface of the catheter the fractured area appeared white and irregular. A review of the device history record revealed no irregularities during the manufacture of the reported lot # 5355258. Conclusion: an absolute root cause for this incident cannot be determined. However, our quality engineer notes that the damage to the returned sample is indicative of catheter recannulation, sear through, and external pulling.
 
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Brand NameBD INTIMA-II¿ CLOSED IV CATHETER SYSTEM 24 G X 0.75 IN.
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 Key6567979
MDR Text Key75208985
Report Number3006948883-2017-00018
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 06/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/15/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2018
Device Catalogue Number383408
Device Lot Number5355258
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 Received04/24/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/15/2017 Patient Sequence Number: 1
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