MAUDE Adverse Event Report: TOGO MEDIKIT CO., LTD. SUPERCATH 5; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Catalog Number SP200-01

Device Problems Fracture (1260); Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/26/2022

Event Type  Injury  

Event Description

On (b)(6), 2022, at a hospital in uruguay, it was reported that supercath5 safety i.V.Catheter was fractured when it was pulled out of a patient's body during a procedure.The fractured portion was surgically removed from the patient's body.There was no reported patient injury as a result of this event.

Manufacturer Narrative

The device involved in the event was not returned.A reproducibility test (such as a tensile strength test) was performed using a stored sample with the lot numbers listed below that had the possibility to be the same lot number as that involved in this event.Also, the investigation was conducted by reviewing the records of the manufacturing processes of the iv catheter with the lot numbers listed below, and it was confirmed that there were no manufacturing processes that caused or contributed to the event, and there were no manufacturing records of visual inspections that showed the cause of or contribution to the event.Judging from this examination, a possible cause of this fracture is that repeated bending of the catheter occurred during the indwelling because of insufficient fixation of the device to a patient's body.This resulted in a decrease in tensile strength of the catheter to a point where the catheter could not withstand the pull force and fractured.Lot#: 21k05s3, 21k05s4 and 21k05s5.

• Brand Name: SUPERCATH 5
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): TOGO MEDIKIT CO., LTD.; 17148-6 aza kamekawa; oaza hichiya; hyuga city, miyazaki prefecture 883-0 062; JA 883-0062
• Manufacturer (Section G): TOGO MEDIKIT CO., LTD.; 17148-6 aza kamekawa; oaza hichiya; hyuga city, miyazaki prefecture 883-0 062; JA 883-0062
• Manufacturer Contact: samuel brown ; 789 n. dixboro road; ann arbor, MI 48105 ; 2024554258
• MDR Report Key: 16277446
• MDR Text Key: 308543877
• Report Number: 9612126-2023-00004
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: UY
• PMA/PMN Number: K140419
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SP200-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Required Intervention