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

MAUDE Adverse Event Report: TERUMO PHILIPPINES CORPORATION SURFLO IV CATHETER CATHETER,INTRAVASCULAR,THERAPEUTIC

  • 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 PHILIPPINES CORPORATION SURFLO IV CATHETER CATHETER,INTRAVASCULAR,THERAPEUTIC Back to Search Results
Catalog Number SR-OX2225CA
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Rash (2033); Burning Sensation (2146)
Event Date 02/18/2016
Event Type  malfunction  
Manufacturer Narrative
The actual device was not returned to the manufacturing facility for evaluation. Therefore, the investigation was based upon evaluation of user facility information and evaluation of retention samples of the involved product/lot number combination. Visual inspection revealed no defects. The coating of silicone was confirmed to be present and met manufacturing specifications. Needle penetration of all retention samples were tested and met manufacturer specifications. Each lot was tested for endotoxin thru limulus amebocyte lysate test to check for the presence of bacterial endotoxin on finished products and met specification for endotoxin limit for medical devices. In addition, qc performs monthly checks of the physical and chemical properties of the sterile products per needle gauge through the physicochemical test. Test items include test for acidity/alkalinity and traces of metals such as cadmium, lead, iron, zinc and tin. Our products comply with iso 10993-1; biological evaluation for medical devices. Also, all finished product are sterilized prior to shipment. There is no evidence that this event was related to a device defect or malfunction and the exact cause cannot be determined based on the available information from the user facility and investigation results. (b)(4). All available information has been placed on file in quality assurance for appropriate tracking, trending and follow-up.
 
Event Description
The user facility reported a patient experienced a burning sensation and then a rash broke out when using sr-ox2225ca device. Follow up communication with the user facility reported: the needle was inserted into the vein and the patient experienced burning sensation and then a rash broke out. They tried a second catheter in the other arm and the patient had the same reaction. Additional information was received from the facility on 2/22/2016. Details for procedure as follows: the patient comes in for iv vitamin c drip weekly; it was reported they use alcohol prep pads purchased from (b)(4) to prep the iv site; they noted a reaction with introduction of first catheter immediately; they removed and switched to other arm, and within a few minutes he experienced the same burning and slight rash; the patient stated he could tolerate the discomfort to continue treatment; the doctor provided the information regarding patient impact, the rash eventually subsided as well as the burning, by the conclusion of 40 minute drip; the doctor followed up with patient's mother today to see how he is doing; it was reported the patient was fine when he left the facility after treatment; the doctor reported the patient has never had a reaction with these treatments before. See mdr no. 3003902955-2016-00016 for the report related to the second device used on the patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSURFLO IV CATHETER
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC
Manufacturer (Section D)
TERUMO PHILIPPINES CORPORATION
124 east main avenue
laguna technopark
binan, laguna
RP
Manufacturer (Section G)
TERUMO PHILIPPINES CORPORATION
124 east main avenue
laguna technopark
binan, laguna, reg. no. 3003902955
RP
Manufacturer Contact
jennifer suh
reg. no. 2243441
2101 cottontail ln.
somerset 08873
8002837866
MDR Report Key5510150
MDR Text Key40653691
Report Number3003902955-2016-00017
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133280
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 03/18/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/18/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2020
Device Catalogue NumberSR-OX2225CA
Device Lot Number151016SC
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 Received02/18/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/16/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-