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U.S. Department of Health and Human Services

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

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TOGO MEDIKIT CO. LTD. SUPERCATH 5 CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
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.
 
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Brand NameSUPERCATH 5
Type of DeviceCATHETER, 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 Key10166154
MDR Text Key195532944
Report Number9612126-2020-00009
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K140419
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
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 Received06/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberSP202-01
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/21/2020
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 Treatment Data
Date Received: 06/18/2020 Patient Sequence Number: 1
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