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U.S. Department of Health and Human Services

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

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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); Unspecified Infection (1930); Swelling (2091); Blood Loss (2597)
Event Type  malfunction  
Manufacturer Narrative
Ethnicity - patient involved was a canine. Race - patient involved was a canine. Implanted date: device was not implanted. Explanted date: device was not explanted. The actual sample was not returned to the manufacturing facility for evaluation. Therefore, the investigation was based upon the user facility information and the evaluation of five retention samples from the reported lot. The retention samples were evaluated by microscopic investigation, and no defective properties were found. All samples were compliant per iso 10993. The user facility reported similar events from the same product code/lot number combination. See mdrs 9681835-2018-00005, 9681835-2018-00006, and 9681835-2018-00007. A review of the manufacturer inspection record for the reported lot was conducted with no findings. The evaluation of the actual device could not be conducted due to the device not being returned. (b)(4).
 
Event Description
The user facility reported that a customer contacted distributer to report that they "have been experiencing vein blow which then is causing infections with swelling and fever with the 22x1 surflash catheter". The patient involved is a dog. The procedure outcome was cleared and the patient did recovered. It was reported that the estimated blood loss was <250cc.
 
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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 Key7235294
MDR Text Key99195509
Report Number9681835-2018-00008
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
Report Date 02/01/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/01/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberSR-FF2225
Device Lot Number161604D
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 Received01/09/2018
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

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