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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CORPORATION - KOFU SURFLO IV CATHETER CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

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TERUMO CORPORATION - KOFU SURFLO IV CATHETER CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Catalog Number SR-OT2232C
Device Problem Break (1069)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 07/14/2020
Event Type  Injury  
Manufacturer Narrative
Expiration date: unknown due to unknown lot number. Udi: udi number is not required for this product code. Implanted date: device was not implanted. Explanted date: device was not explanted. Device manufacture date: unknown due to unknown lot number. The actual device was returned for evaluation. Visual inspection revealed that a part of the catheter was snapped off and the catheter length was found to be 8mm shorter than a normal product. The damaged portion was observed under a microscope. Inverted v-shape damage, in which inner-needle had possibly created while it was being punctured through the catheter, was observed. Furthermore, tensile stress was also observed on the catheter. Ifu states: "do not attempt to re-insert a partially or completely withdrawn needle. " the production lot number was not provided by the user facility. The manufacture inspection records for the past five years were traced and reviewed, and no irregularity was observed. Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction. Based on the investigation results it is likely that an object with a sharpened edge, such as the inner needle, contacted the catheter and created a scratch, which resulted in the catheter fracture after tensile stress was applied. However, the exact cause of the reported event cannot be definitively determined based on the available information. (b)(4).
 
Event Description
The user facility reported that the surflo iv catheter was inserted at 12:00pm on the 13th, and that arterial blood had been monitored from the a line. When checked at 1:00am on the 14th, the monitor was not responding, even though the nurse moved the catheter. The catheter was fixed again, and the doctor removed it at 2:00am. At that time, the doctor found the tip of the catheter was separated. The location of the catheter fragment has been identified and the attempt to remove the fragment is ongoing. The specific location of the catheter fragment was confirmed through echography. The fragment remains in the peripheral blood vessel and there may be higher risk if it is removed, the patient condition is still being monitored. There were no other devices or equipment used with the reported product.
 
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Brand NameSURFLO IV CATHETER
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
TERUMO CORPORATION - KOFU
1727-1, tsuiji-arai
showa-cho
nakakoma-gun, yamanashi 409-3 853
JA 409-3853
Manufacturer (Section G)
TERUMO CORPORATION - KOFU
reg. no. 9681835
1727-1, tsuiji-arai
showa-cho, nakakoma-gun 409-3 853
JA 409-3853
Manufacturer Contact
theresa mussaw
950 elkton blvd
elkton, md 
2837866718
MDR Report Key10374468
MDR Text Key202700800
Report Number9681835-2020-00004
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K891087
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 08/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberSR-OT2232C
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/15/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/14/2020
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: 08/06/2020 Patient Sequence Number: 1
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