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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CORPORATION - KOFU TERUMO SURFLASH I.V . CATHETER INTRAVASCULAR CATHETER

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TERUMO CORPORATION - KOFU TERUMO SURFLASH I.V . CATHETER INTRAVASCULAR CATHETER Back to Search Results
Catalog Number SR-SFF2032
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 04/13/2018
Event Type  Injury  
Manufacturer Narrative
Patient identifier - requested, not provided. Age & date of birth - requested, not provided. Sex - requested, not provided. Weight - requested, not provided. Ethnicity - requested, not provided. Race - requested, not provided. Lot number - requested, not provided. Expiration date - requested but unknown due to lot number being unknown. Udi - the corresponding lot is not subjected for udi. Implanted date: device was not implanted. Explanted date: device was not explanted. Initial reporter: (b)(6). Device manufacture date - requested but unknown due to lot number being unknown. The actual device has been returned to the manufacturing facility for evaluation. The actual sample was verified one piece at time. The catheter portion was 24mm long on the hub. Beacuse the found fragment piece was approximately 6. 5mm long, no other portion is missing. Visually confirmed at 12mm away from the damage and at the hub connection traces of the catheter were also bent. The damaged portion was closely observed under microscope, the inverted v-shape damage, in which inner-needle had created while it was being punctured through the catheter, was observed. Furthermore, tensile stress was also observed on the catheter. The potential for such an event is addressed in the instructions-for-use (ifu) with statements as the following: "do not attempt to re-insert a partially or completely withdrawn needle. " the manufacture inspection record was traced back five years. No defective properties to degrade functionality of the needle; such as any scratches/bends that was being inspected during production, were noted. 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).
 
Event Description
The user facility reported while the surflo was being inserted, the patient claimed discomfort. When a healthcare professional attempted to remove, one felt like it was stuck under the skin. The healthcare professional later switched to an experienced anesthesiologist. Even though the anesthesiologist also attempted to withdraw it straight, it was still not removable so that tilted it sideways. When finally removed from the patient, tip portion was found to be damaged and separated. Surgical incision was taken and the missing portion was found and removed safely from the patient. According to the nurse who cared the patient, one was successfully able to secure the vein at once. Hence re-insertion or to re-locate the inner-needle for proper insertion into the vein, had never been performed. Catheter fragment was safely removed from the patient. The current condition of the patient is reported to be recovered.
 
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Brand NameTERUMO SURFLASH I.V . CATHETER
Type of DeviceINTRAVASCULAR CATHETER
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 Key7513683
MDR Text Key108233117
Report Number9681835-2018-00012
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 05/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/15/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberSR-SFF2032
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/19/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/16/2018
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: 05/15/2018 Patient Sequence Number: 1
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