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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 SP200-01
Device Problems Fracture (1260); Material Separation (1562)
Patient Problem Foreign Body In Patient (2687)
Event Date 05/09/2019
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 lot numbers listed below that had the possibility to be the same lot number as that involved in the event. Also, the investigation was conducted by reviewing the records of 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#:18e30a1, 18e30a6 and 18e30a7.
 
Event Description
On (b)(6)2019, at a hospital in (b)(6), it was reported that supercath5 safety i. V. Catheter was found to be fractured by the confirmation of the device because of the leakage of medical solution from the device during an infusion. The fractured portion was surgically removed from the patient's body. 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 Key8666067
MDR Text Key146903486
Report Number9612126-2019-00005
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K140419
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Type of Report Initial
Report Date 06/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberSP200-01
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/10/2019
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 Treatment Data
Date Received: 06/04/2019 Patient Sequence Number: 1
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