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

Catalog Number	SR*FF2419
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier - (b)(6).Date of birth - (b)(6) year old cat, but the exact dob was unreported.Patient involved was a feline.Device manufacture date - is between april 7 - april 9, 2017.Implanted date: device was not implanted.Explanted date: device was not explanted.A photo image of the actual sample was obtained for evaluation.The actual sample has not been returned.Therefore, the investigation was based upon the user facility information, the photo image, and the retention samples.The photo was closely checked and revealed that the portion remaining was approximately 1/3 of normal length and slightly curved.Retention samples were evaluated by visual inspection, and no defective properties were found.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.A review of the manufacturer inspection record for the reported lot was conducted with no findings.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 user facility reported a catheter was placed yesterday morning and removed this evening, part of the inner sheath was left inside.Surgically removed from the cat.Additional information was received on 2/16/18: surgical intervention did not take place, as initially reported.Additional information was received on 2/20/18: it was reported that the catheter was placed on (b)(6) 2018 in right cephalic in feline male cat.The feline was being treated for renal failure.Catheter was placed for approximately 24 hours, with no leakage noted during placement, and no known difficulty during vein entry.Upon removal of catheter, at conclusion of treatment, it was noted approximately 1/2 of catheter was missing.The facility was not able to find the catheter in vein, and performed x-rays.They were still not able to locate the catheter, however they released the feline to owner's care, with feline failing health due to renal failure.Feline did not show any ill effects of catheter migration.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device return date and the completed investigation results.The actual device was returned to the manufacturing facility for evaluation.Verification of the actual sample was compared between the actual sample piece and normal sample piece, catheter tube of the actual sample was observed to be damaged and remained only 12mm long on the hub.The damaged portion was closely observed under microscopic observation, the cross-section of the tube showed a clean straight-cut.As a result of our verification, the damage has been presumed to be made by sharp object cutting through the tube.A visual inspection was conducted on our retention samples to check potential damages in catheter and the inner-needle.As a result, no irregular finding that could have lead potential catheter damage was found.A review of the manufacturer inspection record for the concerned lot revealed no defective properties, such as catheter damage or scratch to degrade functionality of catheter were detected.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.(b)(4).Exemption number e2015026.

• 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: 7324552
• Report Number: 9681835-2018-00003
• Device Sequence Number: 1455984
• Product Code: FOZ
• UDI-Device Identifier: 04987350743534
• UDI-Public: 04987350743534
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 03/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: SR*FF2419
• Device Lot Number: 170406A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/13/2018
• Supplement Date Received by Manufacturer: 03/30/2018
• Initial Report FDA Received Date: 03/08/2018
• Supplement Report FDA Received Date: 04/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 13 YR
• Patient Weight: 5