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

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.Device not returned to manufacturer.

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 moore medical 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.3003902955-2016-00017 for the report related to the second device used on the patient.

• Brand Name: SURFLO IV CATHETER
• Type of Device: CATHETER,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 Key: 5510192
• MDR Text Key: 40663767
• Report Number: 3003902955-2016-00016
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: SR-OX2225CA
• Device Lot Number: 151016SC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1