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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 INTERVASCULAR CATHETER

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BD (SUZHOU) BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTERVASCULAR CATHETER Back to Search Results
Catalog Number 383078
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problems Inflammation (1932); Swelling (2091); Device Embedded In Tissue or Plaque (3165)
Event Date 12/29/2018
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.
 
Event Description
It was reported that the bd intima-ii¿ closed iv catheter system left a broken cannula after insertion. Customer said "the nurses pulled out the needles at the request of their families around 11 a. M. , (b)(6) 2018. When they pulled out the catheter, they found that they were broken. Immediately report to the nursing department and take emergency measures to confirm the location of the residual catheter in the temporofrontal region by x-ray and three-dimensional color doppler ultrasonography. On the afternoon of (b)(6), after consultation with surgeons, the catheter was sent to the operating room at about 17:30, and the operation ended at about 18:20, with unknown results. When the catheter was pulled out, it was found that it was broken in the middle of the catheter, and there was no abnormality at the puncture point except for slight redness and swelling. ".
 
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Brand NameBD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
Type of DeviceINTERVASCULAR 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 Key8257384
MDR Text Key133512633
Report Number3006948883-2018-00431
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
N/A
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 03/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/05/2021
Device Catalogue Number383078
Device Lot Number8079077
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 Received12/29/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/20/2018
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: 01/17/2019 Patient Sequence Number: 1
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