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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 01/21/2016
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, 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)(64) 2016, at which time a new iv was placed. 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. On (b)(6)2016, the patient claimed that the vein in his hand had become hard. There was no obvious swelling but a thrombus was identified by a color doppler ultrasound. The nurse applied topical magnesium sulfate and alcohol to the patient's iv insertion site to help relieve pain. The patient also received "chinese traditional medicine" via iv infusion to dissolve the thrombus. The patient recovered on (b)(6) 2016.
 
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 Key5481321
MDR Text Key39744631
Report Number3006948883-2016-00004
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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