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

Catalog Number SP202-01

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

Patient Problem Foreign Body In Patient (2687)

Event Date 05/21/2020

Event Type  Injury  

Manufacturer Narrative

The actual item of the event was returned.Returned product was inspected and reproducibility tests were conducted using the fractured surface of same type of product which has been broken by pulling in the same way.As a result, it was confirmed that the fractured surface of the tested part and the fractured surface of the returned catheter were similar to each other and the fracture was most likely caused by applying a strong tensile force applied instantaneously.Judging from this examination, a possible cause of this fracture is that a patient himself/herself has pulled the device with a force greater than acceptable level.As a result, the catheter could not endure the tensile strength, and broke.

Event Description

On (b)(6) 2020, 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 by the patient during an infusion.The damaged part was found under the patient's bed.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, 883-0 062; JA 883-0062
• Manufacturer (Section G): TOGO MEDIKIT CO. LTD.; 17148-6 aza kamekawa; oaza hichiya; hyuga city, 883-0 062; JA 883-0062
• Manufacturer Contact: yashaswini patwardhan ; amselweg 5; rheda-wiedenbrueck, 33378 ; GM 33378
• MDR Report Key: 10166154
• MDR Text Key: 195532944
• Report Number: 9612126-2020-00009
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K140419
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SP202-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/21/2020
• 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