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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GRIPPER PLUS SAFETY NEEDLE; SET, ADMINISTRATION, INTRAVASCULAR
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GRIPPER PLUS SAFETY NEEDLE; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-2768-24
Medical Device Problem Code Mechanical Problem (1384)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event Malfunction
Event or Problem Description
It was reported the device safety mechanism "broke off" and so the safety mechanism did not work.No adverse effects reported.
 
Additional Manufacturer Narrative
Other, other text: returned device was received for evaluation.During the evaluation of the device the customer reported condition was confirmed.It is concluded that the failure could be reproduce in the test 2 when the safety mechanism was not lift based instruction for use.Problem source is unknown.A manufacturing dhr review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.No causes or potential causes of the customer's reported problem were found during the review of service and repair records.
 
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Brand Name
GRIPPER PLUS SAFETY NEEDLE
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
MDR Report Key11606347
Report Number3012307300-2021-02778
Device Sequence Number3668003
Product Code FPA
UDI-Device Identifier10610586025617
UDI-Public10610586025617
Combination Product (Y/N)N
Initial Reporter CountryGM
PMA/510(K) Number
K021999
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,user facility
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 08/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number21-2768-24
Device Catalogue Number21-2768-24
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/23/2021
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 03/02/2021
Supplement Date Received by Manufacturer07/12/2021
Initial Report FDA Received Date04/01/2021
Supplement Report FDA Received Date08/05/2021
Was Device Evaluated by Manufacturer? (Y/N) Yes
Is the Device Labeled for Single Use? (Y/N) No
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device N
Patient Sequence Number1
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