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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 383403
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Pain (1994); Thrombus (2101)
Event Date 01/18/2016
Event Type  Injury  
Manufacturer Narrative
(b)(6). A sample is available for evaluation. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that on (b)(6) 2016 at 11:50, a bd intima-ii closed iv catheter system was inserted into a patient for infusion therapy after surgery. The iv remained in the patient until (b)(6) 2016, at which time a new iv was placed. Another new iv was also placed on (b)(6) 2016. On (b)(6) 2016, the patient complained of pain at the iv insertion site so a nurse used a steel cannula for the patient's infusions instead (from (b)(6) 2016 - (b)(6) 2016). A thrombus was identified in the patient's vein by a color doppler ultrasound. The patient received oral "chinese traditional medicine" to dissolve the thrombus.
 
Manufacturer Narrative
Correction: the initial mdr reported this incident as both an adverse event and product problem. A correction is being submitted to report the incident as an adverse event only.
 
Manufacturer Narrative
Results: although it was initially reported that a sample would be available for evaluation, a sample was not returned. A review of the device history record and the device sterility record revealed no irregularities during the manufacture of the reported lot # 5229059. Conclusion: without a sample, an absolute root cause for this incident cannot be determined. A sample was not returned for evaluation.
 
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Brand NameBD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
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 Key5481320
MDR Text Key39745003
Report Number3006948883-2016-00005
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K100775
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,Followup
Report Date 03/18/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2018
Device Catalogue Number383403
Device Lot Number5229059
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 Received02/19/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/17/2015
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: 03/04/2016 Patient Sequence Number: 1
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