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U.S. Department of Health and Human Services

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

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TERUMO CORPORATION - KOFU SURSHIELD SAFETY I.V. CATHETER INTRAVASCULAR CATHETER Back to Search Results
Catalog Number SR-SFA2419
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/22/2018
Event Type  malfunction  
Manufacturer Narrative
Udi - the corresponding product type is not subjected for udi. Implanted date: device was not implanted. Explanted date: device was not explanted. Initial reporter: mr. /ms. (b)(6). The user facility reported that when the device was removed from the patient, it was temporarily placed in a kidney basin. Because the needle was unshielded by the safety-cover while it was being withdrawn, the sharp tip was fully exposed. It is unconfirmed whether the needle was properly shielded by the cover while it was being withdrawn. The actual sample was returned to the manufacturing facility for evaluation. The actual sample verified that the safety-cover was not being properly shielded tip of inner needle and was loosely stayed on its half way to the tip. The safety-cover was closely examined under microscopic observation and had no findings of irregularities to attribute detachment of any parts, deformation or malfunction of the device. Next, the catheter-hub was prepared which was brought from our retention sample, was placed it onto the actual sample to create original assembly. It was used to simulate and verify the proper shielding, performance of the sample. Inner-needle pulling was conducted repeatedly 10 times. As a result, the safety cover was confirmed to be safely activated to shield the tip of inner-needle. The potential for such an event is addressed in the instructions-for-use (ifu) with statements as the following: "if the safety mechanism fails to activate, carefully dispose the product appropriately", "for certain activation of safety mechanism, be careful not to withdraw the inner needle at an extreme angle or rotating or too quickly. ", and "do not touch the safety cover after withdrawal of the inner needle for infection prevention. " the manufacture inspection record was traced back and reviewed up to five years, in which duration is equivalent to expiration of the product and reviewed. As a result, no similar event was noted in the record. 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 that when the terumo surshield safety i. V. Catheter device was removed from the patient, it was temporarily placed in a kidney basin. Because the needle was unshielded by the safety-cover while it was being withdrawn, the sharp tip was fully exposed. It is unconfirmed whether the needle was properly shielded by the cover while it was being withdrawn.
 
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Brand NameSURSHIELD SAFETY 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 Key7613391
MDR Text Key112310952
Report Number9681835-2018-00023
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K082362
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 06/19/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberSR-SFA2419
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/25/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/23/2018
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

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