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

Catalog Number SROX1832V

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Edema (1820); Unspecified Infection (1930); No Code Available (3191)

Event Date 08/26/2016

Event Type  Injury  

Manufacturer Narrative

Although this report is related to a product that is labeled for use in the veterinary market, the product is identical to product that is labeled for human use.Therefore, this report is being submitted as a precautionary measure.(b)(4).The actual device was not returned to the manufacturing facility for evaluation however three unused and unopened samples were returned for evaluation.Therefore, the investigation was based upon evaluation of user facility information, three unused samples and evaluation of retention samples of the involved product/lot number combination.Visual inspection of the three unused samples and retention samples revealed no defects.Magnification of the three unused samples revealed no defects.Inspection of the retention samples confirmed the coating of silicone was present and met manufacturing specifications.Needle penetration of the three returned unused samples and 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 (b)(4); biological evaluation for medical devices.Also, all finished product are sterilized prior to shipment.A review of the device history record of the product code/lot# combination was conducted with no relevant findings.There is no evidence that this event was related to a device defect or malfunction.The exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).All available information has been placed on file in quality assurance for appropriate tracking, trending and follow-up.

Event Description

A distributor reported an infection on an animal patient using (b)(4) device.Follow up communication with the user facility reported: it was reported that an animal patient was presented on (b)(6) 2016 with vomiting; the animal patient was diagnosed and treated for gastro-intestinal parasites; the animal patient reacted well to medicine and was eating and discharged thursday (b)(6) 2016; it was reported that the owners brought the animal patient back on friday, (b)(6) presented with a fever of 105 and noted edema at the iv site; the animal patient was treated with cephalexin antibiotic; it was reported that the animal patient reacted well, and was released from the hospital; and it was reported that the animal patient is doing well.The user facility reported a similar complaint related to another device from the same product code/lot number; see mdr no.3003902955-2016-00029.

• Brand Name: SURVET 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: 5980282
• MDR Text Key: 55729880
• Report Number: 3003902955-2016-00030
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: SROX1832V
• Device Lot Number: 140901SD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2014
• 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
• Treatment: ANTIBIOTIC (CEPHALEXIN)
• Patient Outcome(s): Required Intervention
• Patient Age: 06 MO