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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD INC., DELCO GRIPPER MICRO NEEDLE SET, ADMINISTRATION, INTRAVASCULAR

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SMITHS MEDICAL ASD INC., DELCO GRIPPER MICRO NEEDLE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 21-3271-24
Device Problems Difficult to Remove (1528); Device Operational Issue (2914)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/13/2016
Event Type  malfunction  
Manufacturer Narrative
One used deltec® gripper micro® needle was returned for investigation. The device history record was reviewed and no discrepancies were found. A visual inspection was performed and showed the needle was slightly bent approximately 8-10 degrees. Functional testing confirmed the complaint; excessive force was required to activate the safety mechanism. A manufacturing review of a similar device was performed and no discrepancies were found. The most likely root causes were determined to be either that the operator did not follow manufacturing procedures and did not perform a visual inspection to detect the bent needle, or the product got damaged after leaving the manufacturing site.
 
Event Description
This procedure was performed in (b)(6). The customer stated that the patient needed to be re-assessed after the nurse inserted the port access needle. The safety mechanism was not able to be engaged and sharp could not be removed. Three nurses tried to disengage the safety mechanism with no success. They could not confirm placement because blood cannot be withdrawn with the safety mechanism in place. The access needle had to be removed and the patient required another poke with a new gripper micro needle. The next needle functioned as normal.
 
Manufacturer Narrative
One used deltec® gripper micro® needle was returned for investigation. The device history record was reviewed and no discrepancies were found. A visual inspection was performed and showed the needle was slightly bent approximately 8-10 degrees. Functional testing confirmed the complaint; excessive force was required to activate the safety mechanism. A manufacturing review of a similar device was performed and no discrepancies were found. The most likely root causes were determined to be either that the operator did not follow manufacturing procedures and did not perform a visual inspection to detect the bent needle, or the product got damaged after leaving the manufacturing site.
 
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Brand NameDELCO GRIPPER MICRO NEEDLE
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD INC.,
1265 grey fox rd
st. paul MN 55112
Manufacturer (Section G)
SMITHS MEDICAL ASD INC.,
1265 grey fox rd
st. paul MN 55112
Manufacturer Contact
michele seliga
1265 grey fox rd
st. paul, MN 55112
7633833052
MDR Report Key5742855
MDR Text Key47996556
Report Number2183502-2016-01223
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K072059
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/25/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/22/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2021
Device Catalogue Number21-3271-24
Device Lot Number36X195
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/10/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/31/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/03/2016
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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