MAUDE Adverse Event Report: TERUMO PHILIPPINES CORPORATION SURVET IV CATHETER

Catalog Number SROX2225V

Device Problem Fracture (1260)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 12/28/2015

Event Type  malfunction  

Manufacturer Narrative

Note: 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.This report was not associated with a human patient.The actual device has not been received by the manufacturing facility for evaluation.A follow up report will be submitted when the investigation is complete, but no later than 30 days from the date this report was sent.Terumo medical products (tmp) (b)(4) is submitting this report on behalf of terumo (b)(4).All available information has been placed on file in quality assurance for appropriate tracking, trending and follow-up.Device not received by manufacturer.

Event Description

The user facility reported the survet iv catheter was severed when removed from the animal patient.Follow up communication with the user facility reported: (1) the catheter was inserted into the vein without a problem and they saw flashback; (2) the catheter would not flush; (3) they removed the catheter and noticed a clean (partial) cut.Additional information was reported on 12/30/15: (1) the vet tech confirmed a clean break was noted upon catheter removal; (2) further clarification indicated the catheter did not fully break, but presented a partial sever, approximately 2/3 through the catheter; (3) the partial sever was noted 1/3 from the distal end of the catheter; (4) the doctor noted the catheter did not flush or "feel right", and upon removal noted the lack of flushing was due to the partial sever; and (5) there was no impact to the animal patient.

Manufacturer Narrative

This report is being submitted as follow up no.1 for mfg.Report no.3003902955-2016-00001 to provide the returned sample evaluation and the 510k number.The lot number is unknown for this complaint.The following are potential lot numbers for the reported product code: (srox2225) (1) 150224sc (2) 150304sc.The actual device was not returned for evaluation, however eight unused samples of the above stated potential lot numbers were returned for evaluation.Therefore, the investigation was based on evaluation of user facility information, eight returned unused samples and retention samples of the above stated product/lot combinations.Visual evaluation of the eight unused samples and retention samples revealed no defects.The catheter tube (as raw material) has been evaluated and confirmed to meet manufacturer specification.The catheter tube is made up of ethylene tetrafluoroethylene (etfe) material which has high tensile strength.The catheter tube testing for tensile strength was conducted and confirmed to meet manufacturer specification.The returned unused samples were subjected to catheter tube and catheter hub fitting force testing and confirmed to meet manufacturer specification.Functional testing could not reproduce the reported failure.A review of the device history records for the potential lots was conducted with no relevant findings.Prior shipment, qc conducts outgoing visual inspection and testing for all assembled catheters and all samples for the potential complaint lots passed.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

This report is being submitted as follow up no.1 for mfg.Report no.3003902955-2016-00001 to provide the returned sample evaluation and the 510k number.

• Brand Name: SURVET IV CATHETER
• Type of Device: CATHETER
• 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: 5391157
• MDR Text Key: 36852039
• Report Number: 3003902955-2016-00001
• 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,Followup
• Report Date: 01/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: SROX2225V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 12 YR