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U.S. Department of Health and Human Services

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

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TERUMO CORPORATION - KOFU SURFLASH PLUS SAFETY I.V. CATHETER SURFLASH SAFETY I.V. CATHETER Back to Search Results
Catalog Number SR-FVP2225
Device Problem Physical Resistance (2578)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/16/2017
Event Type  malfunction  
Manufacturer Narrative
Udi number is not required for the reported device. Device manufacturer date - 05/04/2017 thru 05/08/2017. The actual device was not returned for evaluation. Therefore, the investigation was limited to three retention samples from the reported product code/lot number combination. The inner-needle was closely examined by withdrawing it from the catheter in a straight backward motion. As a result, it was confirmed the safety cover was properly able to shield the tip of inner-needle as intended. A review of the manufacturer inspection records was conducted with no findings. Visual inspection conducted after the product assembly also showed no product with defective activation of the safety-cover. Furthermore, there has been no similar incidents ever reported for the concerned lot by other medical institution. The investigation confirmed that the retention samples were the normal product. With no device return, the exact cause of the reported event cannot be definitively determined. The device labeling does address the potential for such an event in the instructions-for-use (ifu) with statements such as the following: do not grasp at the junction of hub and tip of the safety mechanism to disconnect. To assure activation of safety mechanism; withdraw the inner needle with care while avoiding an extreme angle or rotating motion. (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The user facility reported that while the inner-needle was being withdrawn after successful catheter placement, a strong sense of resistance was experienced and the safety cover did not activate as intended. There is no known impact to the patient.
 
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Brand NameSURFLASH PLUS SAFETY I.V. CATHETER
Type of DeviceSURFLASH SAFETY I.V. 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 Key7070042
MDR Text Key93715572
Report Number9681835-2017-00039
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K123267
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 11/30/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/30/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2019
Device Catalogue NumberSR-FVP2225
Device Lot Number170506A
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 Received10/31/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/04/2017
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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