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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CORPORATION - KOFU SURFLASH® PLUS SAFETY I.V. CATHETER CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM

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TERUMO CORPORATION - KOFU SURFLASH® PLUS SAFETY I.V. CATHETER CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM Back to Search Results
Catalog Number SR-FVP2225
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Fever (1858); Inflammation (1932); Pain (1994); Thrombus (2101)
Event Type  Injury  
Manufacturer Narrative
Udi - not required for this product code/lot number combination. The actual device was not returned to the manufacturing facility for evaluation. A safety assessment had been conducted on the reported product and confirmed the product to be safe. The investigation is still being conducted. A follow up report will be submitted within 30 days of this report being sent. A search of the complaint file found no other report with the involved product code. (b)(4). All available information has been placed on file in quality assurance for tracking, trending, and follow up. Device not returned to manufacturer.
 
Event Description
The user facility reported a patient had a reaction with the involved device. Follow up communication with the user facility reported: the hospital has utilized picc manufactured by other companies on their patients, this one specific patient was reported to have suffered engorgement, local heat sensation and a lump that was later found to be thrombus; the doctor removed the picc and used a surflo v3 device; it was reported that two to three days later, the patient started to suffer from other symptomatic states such as reddening, fever, local heat sensation, pain and especially strong engorgement; a steroid drug was injected into the patient; and the procedure outcome and the current patient condition is currently being investigated.
 
Manufacturer Narrative
This report is being submitted as follow up no. 1 to provide the additional event description and the completed investigation results. Based on the limited product information provided and no return of the actual device, no probable root cause could be determined. All available information has been placed on file in quality assurance for tracking, trending, and follow up.
 
Event Description
The sales representative reported according to the doctor who has been observing the condition of the concerned patient, "no steroid was administrated, although a patient had to suffer with "intense engorgement" using picc, before switching to srv-3. Once the initial symptom with srv-3 had been observed, they administrated a steroid to the patient and it helped to ease the patient's condition and the patient eventually recovered. The next phase in the anti-cancer drug treatment has currently taken place. Implementation of an allergic patch test will be performed shortly after the patient's chemotherapy has ended and when the number of blood cells return to normal.
 
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Brand NameSURFLASH® PLUS SAFETY I.V. CATHETER
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM
Manufacturer (Section D)
TERUMO CORPORATION - KOFU
1727-1, tsuiji-arai
showa-cho
nakakoma-gun, yamanashi 409-3 583
JA 409-3583
Manufacturer (Section G)
TERUMO CORPORATION - KOFU
reg. no. 9681835
1727-1, tsuiji-arai, showa-cho
nakakoma-gun, yamanashi 409-3 583
JA 409-3583
Manufacturer Contact
jennifer suh
reg. no. 2243441
2101 cottontail ln.
somerset, NJ 08873
8002837866
MDR Report Key6152145
MDR Text Key61703158
Report Number9681835-2016-00036
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K123267
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/07/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberSR-FVP2225
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/02/2016
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

Patient Treatment Data
Date Received: 12/07/2016 Patient Sequence Number: 1
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