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 03/05/2019

Event Type  Injury  

Manufacturer Narrative

The device involved in the event was returned.The returned device was examined and the repeatability test (tensile strength testing etc.) was conducted using reserved samples with the same lot number as that involved in the event.Also, the investigation was conducted by reviewing the records of the manufacturing processes of the iv catheter with the same lot number as that involved in the event, 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 a sharp object (such as inner needle) came into contact with the catheter and 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#: 18h09c2.

Event Description

On (b)(6) 2019, at a hospital in (b)(6), it was reported that supercath5 safety i.V.Catheter was fractured when it was pulled out of a patient's body during a procedure.There was a possibility that the fractured portion fell off when a fixing tape was peeled off, since the presence of the fractured portion was not confirmed in the patient's body.There was no reported patient injury as a result of this event.

• 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: yashaswini patwardhan ; amselweg 5; rheda-wiedenbrueck, 33378 ; GM 33378
• MDR Report Key: 8486059
• MDR Text Key: 141010542
• Report Number: 9612126-2019-00004
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K140419
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial
• Report Date: 04/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2019
• 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: 18H09C2
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/14/2019
• 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 Outcome(s): Required Intervention