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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL DELTEC® GRIPPER MICRO® BLUNT CANNULA, NON-CORING SAFETY NEEDLE SET, ADMINISTRATION, INTRAVASCULAR

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SMITHS MEDICAL DELTEC® GRIPPER MICRO® BLUNT CANNULA, NON-CORING SAFETY NEEDLE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 21-3256-24
Device Problem Fail-Safe Problem (2936)
Patient Problem Needle Stick/Puncture (2462)
Event Date 07/12/2016
Event Type  Injury  
Manufacturer Narrative
Customer has not yet returned the device to the manufacturer for device evaluation. When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation.
 
Event Description
It was reported that the needle popped out of the safety and a needlestick occurred. Additional information regarding the event and outcome was requested.
 
Manufacturer Narrative
The reported ndl, gripper micro, 20g x 0. 75" was returned for investigation along with an image and a video. The returned device was received on a container without its original packaging. Visual inspection was performed and the needle of the received sample was moved into the opening of the base and re-assembly to re-activate the safety mechanism. The needle was measured using a calibrated caliper and the click from the safety mechanism could be heard. There was no movement of the needle, and there was no part of the needle showing after it had been secured in place. The needle was measured and it was found that the needle was within specification. The picture and video resulted on the picture showing that the needle is out of the out of the safety mechanism, on the video it was detected that the needle came out of the safety mechanism after the click from the safety mechanism was heard and a small pull is applied to the needle. The instructions for use or ifu state that "failure to use safety arm correctly (lift safety arm straight back to the lock position until it clicks) when removing needle from portal site could result in the needle tip re-emerging from the base, resulting in accidental needle stick with a contaminated needle. No root cause has been determined since the complaint was not confirmed. (b)(4).
 
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Brand NameDELTEC® GRIPPER MICRO® BLUNT CANNULA, NON-CORING SAFETY NEEDLE
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL
1265 grey fox rd.
st paul MN 55112
Manufacturer (Section G)
SMITHS HEALTHCARE MFG
s.a.dec.v. ave, calidad no. 4
parque industrial internaciona
tijuana, bc 22425
MX 22425
Manufacturer Contact
lisa perz
1265 grey fox road
st paul 55112
7633833074
MDR Report Key5854740
MDR Text Key51410183
Report Number2183502-2016-01686
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K072059
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/13/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/08/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number21-3256-24
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/29/2016
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: 08/08/2016 Patient Sequence Number: 1
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