MAUDE Adverse Event Report: TERUMO CORPORATION - KOFU SURFLASH I.V. CATHETER

Catalog Number	SR*FF2025
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier - labradoodle.Ethnicity - patient involved was a canine.Race - patient involved was a canine.Implanted date: device was not implanted.Explanted date: device was not explanted.Device manufacture date - 6/28/2017 ~ 6/29/2017.(b)(4).The actual sample was not returned to the manufacturing facility for evaluation.Therefore, the investigation was based upon the user facility information and the evaluation of retention samples.Visual inspection of our retention samples was conducted.No irregular findings including catheter damage or scratches, were observed.A review of the manufacturer inspection record for the reported lot was conducted with no findings.The potential for such an event is addressed in the instructions-for-use (ifu) with statements as the following: "do not attempt to re-insert a partially or completely withdrawn needle." with no device return, the exact cause of the reported event cannot be definitively determined based on the available information.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of kofu factory of terumo corporation (manufacturer) registration no.9681835.Exemption number e2015026.
Event or Problem Description
The tech was removing the catheter, and when they pulled it out they realized it was just the hub, so the doctor went in surgically and retrieved the broken piece (of catheter).Animal patient condition and the procedure outcome was good.Additional information was received on 5/29/2018: the doctor who reiterated the catheter was found to be broken upon removal at conclusion of canine procedure.There was no leakage noted during placement from approximately 10:00 am -5:00 pm.The tech noted the broken catheter and immediately held pressure to keep the catheter from migrating more than a few cm proximal in cephalic vein.The doctor opened up the vein, and removed the catheter with no consequence to the animal.The catheter was removed successfully and was retrieved 2 to 3 cm proximal in the cephalic vein.The canine was released to the owners care and is due to return for first follow-up.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide that the device was available along with the device return date and to provide the completed investigation results.The actual sample was returned to the manufacturing facility for evaluation.The sample was closely observed, catheter damage was observed approximately 22.5mm away from its tip.The damaged portion was further verified through microscopic observation.The cross sectional view of the damage was observed to be clean straight and smooth cut.Based upon presumption that the damage might have been potentially made by a sort of sharp object cutting through the catheter.A review of the manufacturer inspection record for the reported lot was traced back and reviewed with no findings.As a result, no similar event was noted in the record.The potential for such an event is addressed in the instructions-for-use (ifu) with statements as the following: "do not attempt to re-insert a partially or completely withdrawn needle." 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.

• Brand Name: SURFLASH I.V. CATHETER
• Common Device Name: SURFLASH I.V. CATHETER
• Manufacturer (Section D): TERUMO CORPORATION - KOFU; 1727-1, tsuiji-arai; showa-cho; nakakoma-gun, yamanashi 409-3 853; JA 409-3853
• MDR Report Key: 7628772
• Report Number: 9681835-2018-00024
• Device Sequence Number: 2412828
• Product Code: FOZ
• UDI-Device Identifier: 04987350743558
• UDI-Public: 04987350743558
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K991406
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: SR*FF2025
• Device Lot Number: 170628D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/25/2018
• Supplement Date Received by Manufacturer: 06/20/2018
• Initial Report FDA Received Date: 06/22/2018
• Supplement Report FDA Received Date: 07/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 13 YR
• Patient Weight: 20