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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. GRIPPER PLUS® POWER P.A.C. SAFETY HUBER NEEDLE - NON Y-SITE SET, ADMINISTRATION, INTRAVASCULAR

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SMITHS MEDICAL ASD, INC. GRIPPER PLUS® POWER P.A.C. SAFETY HUBER NEEDLE - NON Y-SITE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 21-3367-24
Device Problem Fail-Safe Problem (2936)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/19/2016
Event Type  malfunction  
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. (b)(4).
 
Event Description
It has been reported that while de-accessing port needle from the patient in the oncology department, the safety needle did not stop the needle. As the nurse, who "was proficient with the accessing and de-accessing port-a-cath needles", was performing the de-accessing, she held down the corners of the port needle with her left hand and gently retracted the needle with her right hand. As she was retracting the needle, the needle pulled out and went past the safety gauge and was left exposed. The nurse stated that she used the same technique she always uses. No adverse health outcomes were reported.
 
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Brand NameGRIPPER PLUS® POWER P.A.C. SAFETY HUBER NEEDLE - NON Y-SITE
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS HEALTHCARE MFG
s.a. de c.v. ave, calidad no.
parque industrial internaciona
tijuana, b.c. 22425
MX 22425
Manufacturer Contact
lisa perz
6000 nathan lane north
minneapolis, MN 55442
7633833074
MDR Report Key6107285
MDR Text Key60078937
Report Number3012307300-2016-00368
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K072657
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 10/27/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/16/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number21-3367-24
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 Received10/27/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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