MAUDE Adverse Event Report: ST PAUL GRIPPER PLUS SAFETY NEEDLE; SET, ADMINISTRATION, INTRAVASCULAR,

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
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.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.(b)(6) phone number provided.

• Brand Name: GRIPPER PLUS SAFETY NEEDLE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR,
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 11606345
• Report Number: 3012307300-2021-02780
• Device Sequence Number: 19749831
• Product Code: FPA
• UDI-Device Identifier: 10610586025617
• UDI-Public: 10610586025617
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K021999
• Number of Events Summarized: 1
• 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): 01/18/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: 21-2768-24
• Device Catalogue Number: 21-2768-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2021
• Supplement Date Received by Manufacturer: 07/12/2021
• Initial Report FDA Received Date: 04/01/2021
• Supplement Report FDA Received Date: 01/18/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown