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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SUPERCATH 5 CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

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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 09/11/2021
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 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. It is also possible that the catheter was repeatedly flexed, based on information that the patient was using a fan on his infusion arm. Lot#: 21h02b5.
 
Event Description
On (b)(6) 2021, 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 lack of the flow during an infusion. 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.
 
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Brand NameSUPERCATH 5
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
MDR Report Key12621724
MDR Text Key276169816
Report Number9612126-2021-00006
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 10/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberSP200-01
Device Lot Number21H02B5
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/14/2021
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: 10/13/2021 Patient Sequence Number: 1
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