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U.S. Department of Health and Human Services

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

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TERUMO CORPORATION - KOFU TERUMO SURSHIELD SAFETY I.V. CATHETER INTRAVASCULAR CATHETER Back to Search Results
Catalog Number SR-SFA2032
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Needle Stick/Puncture (2462)
Event Date 05/11/2018
Event Type  malfunction  
Manufacturer Narrative
Udi - the corresponding lot is not subjected for udi. Implanted date: device was not implanted. Explanted date: device was not explanted. (b)(6). Device manufacture date - 12/06/2017 ~ 12/07/2017. The actual sample was returned to the manufacturing facility for evaluation. The sample was closely checked. The safety-cover was not properly shielding a tip of the inner-needle and was being positioned on its way to the tip. The safety-cover portion was examined under microscopic observation and no defective properties were found. Next, prepared was a catheter-hub alone, which was brought from the retention sample, was placed onto the actual obtained sample to create the original assembly. It was used to simulate and verify the proper shielding performance of the sample. Also, conducted was an inner-needle pulling resistance test, which was repeated 10 times. As a result, of verification, the safety-cover was confirmed to be safely activated to shield the tip of the 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" and "for certain activation of safety mechanism, be careful not to withdraw the inner needle at an extreme angle or rotating or too quickly. " a review of the manufacturer inspection record for the reported lot was traced back and reviewed with no 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).
 
Event Description
The user facility reported that a nurse suffered from needle stick injury shortly after withdrawing the inner-needle in the emergency room. The inner-needle was not properly shielded to activate the safety-cover. The nurse never withdrew the needle at an extreme angle or rotated it, according to the facility. There is no infection to the patient a periodical checkup is scheduled. The patient is currently being monitored.
 
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Brand NameTERUMO SURSHIELD 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 Key7581951
MDR Text Key110914779
Report Number9681835-2018-00014
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 06/08/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberSR-SFA2032
Device Lot Number171205H
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/15/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/11/2018
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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