• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CORPORATION - KOFU SURFLASH I.V. CATHETER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

TERUMO CORPORATION - KOFU SURFLASH I.V. CATHETER Back to Search Results
Catalog Number SR*FF2225
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Fever (1858); Swelling (2091)
Event Date 11/30/2017
Event Type  Injury  
Manufacturer Narrative
This report is being submitted as follow up no. 2 to provide a correction to catalog # and lot #. It was initially reported as sr-ff2225 and 170213a. Manufacture date is 08/24/2015-08/25/2017.
 
Manufacturer Narrative
This report is being submitted as follow up no. 1. The conclusion in section was inadvertently entered as (b)(4). The correct have been entered. (b)(4) no failure detected, device opereated within specification: based off retention sample, 67: unable to confirm complaint: based off no sample returned.
 
Manufacturer Narrative
Patient involved was a canine; implanted date: device was not implanted, explanted date: device was not explanted. No results available since no evaluation performed: based off the actual device unavailable to be evaluated, no failure detected: based off the reserve sample evaluated. The actual sample was not available for investigation. Retention samples were observed and no anomalies were found with the needle tip, and there was no contamination inside the needles. Penetration resistance check was performed. A polyethylene sheet with 50-micron thickness was used for insertion resistance and was measured, with values within manufacturer specification. A review of the manufacturer inspection record of the involved lot number revealed no relevant findings. The corresponding product type has been tested in accordance with iso (b)(4) safety inspection (biological evaluation of medical device). (b)(4).
 
Event Description
The user facility reported vein blow. Follow up communication with the user facility reported the following information: customer said they have been experiencing vein blow which then is causing injection with swelling and fever with the 22x1 surflash catheter. They have been using this product since 2015. They said this has occurred a few times. The customer stated that the longer the product was left in the patient, the more likely this issue was to occur. There was medical intervention as the need to provide care to manage phlebitis. All of the animals (dogs) have recovered.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSURFLASH I.V. CATHETER
Type of DeviceSURFLASH I.V. CATHETER
Manufacturer (Section D)
TERUMO CORPORATION - KOFU
1727-1, tsuiji-arai
showa-cho
nakakoma-gun, yamanashi 409-3 853
JA 409-3853
Manufacturer (Section G)
TERUMO CORPORATION - KOFU
reg. no. 9681835
1727-1, tsuiji-arai, showa-cho
nakakoma-gun, yamanashi 409-3 853
JA 409-3853
Manufacturer Contact
terry callahan
reg. no. 2243441
2101 cottontail ln.
somerset, NJ 08873
8002837866
MDR Report Key7142878
MDR Text Key162719453
Report Number9681835-2017-00045
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K991406
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/22/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2020
Device Catalogue NumberSR*FF2225
Device Lot Number150819D
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/24/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-