MAUDE Adverse Event Report: TERUMO CORPORATION - KOFU SURFLO I.V. CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Catalog Number SR-0T1664C

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/10/2018

Event Type  malfunction  

Manufacturer Narrative

Patient identifier - requested but not provided.Age and date of birth - requested but not provided.Sex - requested but not provided.Weight - requested but not provided.Ethnicity - requested but not provided.Race - requested but not provided.Lot number- requested but unknown.Expiration date - requested but not provided.Udi - requested but not provided.Implanted date: device was not implanted.Explanted date: device was not explanted.Device manufacture date - requested but not provided.The actual device was not returned to the manufacturing facility.Therefore, the investigation was limited to information provided by the user facility and review of quality records.A review of the manufacturer inspection record from the past five (5) years 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 tracking, trending, and follow up.

Event Description

The user facility reported catheter damage in this event.Follow up communication with the user facility reported the following information: when thoracentesis was done in a patient, catheter tip was damaged.The patient is bedridden, the doctor comprehensive made his decision not to conduct surgical removal.It was reported that the patient is currently being monitored.Fragment is considered to still being remained in the patient.Additional information was received on 2/8/2018: it was reported that it was unknown if the device fragment is in the patient.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide corrections to sections d1 and d2 as the information that was initially submitted was inadvertently reported incorrectly.

• Brand Name: SURFLO I.V. CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): TERUMO CORPORATION - KOFU; 1727-1, tsuiji-arai; showa-cho; nakakoma-gun, yamanashi 409-3 853; JA 409-3853
• MDR Report Key: 7250998
• MDR Text Key: 99930493
• Report Number: 9681835-2018-00009
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K891087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SR-0T1664C
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1