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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CORPORATION - KOFU SURSHIELD PUR SAFETY I.V. CATHETER CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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TERUMO CORPORATION - KOFU SURSHIELD PUR SAFETY I.V. CATHETER CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Catalog Number SR-SFF2225
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Embolus (1830)
Event Date 09/01/2017
Event Type  Injury  
Manufacturer Narrative
Udi number is not required for the reported device. The actual device was not returned to the manufacturing facility. Therefore, the investigation was limited to information provided by the user facility and review of quality records. A review of the manufacturer inspection record from the past five (5) years was conducted with no relevant findings. There is no evidence that this event was related to a device defect or malfunction. The exact cause of the reported event cannot be definitively determined based on the available information. (b)(4). All available information has been placed on file in quality assurance for tracking, trending, and follow up.
 
Event Description
The user facility reported the patient developed a blood clot. Follow up communication with the user facility reported the following information: after eye surgery, catheter placement was successfully completed in the skin; an anti-coagulant such as heparin, was not dosed to the patient; when maintenance transfusion was prepared and injected, a discomfort feeling was noted by the patient; the catheter was removed within a day and examined; no defective property such as catheter damage, was noted on the device; incision in the skin was implemented to remove the blood clot in vessel; the hospital believes the event was not caused by a defective terumo device but contributed by the patient; and the patient fully recovered from the blood clot removal.
 
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Brand NameSURSHIELD PUR SAFETY I.V. 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, yamanashi 409-3 853
JA 409-3853
Manufacturer Contact
terry callahan
reg. no. 2243441
2101 cottontail ln.
somerset, NJ 08873
8002837866
MDR Report Key6913267
MDR Text Key88105524
Report Number9681835-2017-00030
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K100282
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 10/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/04/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberSR-SFF2225
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/07/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 10/04/2017 Patient Sequence Number: 1
Treatment
INFUSION SET; MAINTENANCE TRANSFUSION (AGENT UNKNOWN)
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