MAUDE Adverse Event Report: ST PAUL DELTEC GRIPPER MICRO NEEDLE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	21-3256-24
Medical Device Problem Codes	Dull, Blunt (2407); Difficult or Delayed Separation (4044)
Health Effect - Clinical Codes	Pain (1994); Anxiety (2328)
Date of Event	06/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cannulas are partly blunt, so repeated puncturing was necessary and the safety closure, which must be removed after puncture, was so tightly attached that a strong pull was necessary.There was no permanent damage and no extravasation, but the repeated puncturing of the cannula caused pain for the patients and fear of further puncturing due to the tight pulling of the closure.No invasive injuries occurred in relation with patients.
Additional Manufacturer Narrative
Other text: a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing was performed.Visual inspection found the safety mechanism inactivated; no damage it can be observed on the base and needle.Functional testing found the sample returned was broken when trying to activate the arm due the needle base was too tight, complaint is confirmed.The root cause of the reported issue was found to be lack of adherence in procedure that indicate to lift the arm just enough to free the site to be turned to the final position, this step is a control process to assure the safety mechanism since this is a purchased component.An awareness notification was made to production personnel to explain the importance to adherence or following the procedure? completed 17/november/2022.This issue will be monitored for any increase in occurrence.If the occurrence of this issue increases significantly, additional investigative action will be taken accordingly.

• Brand Name: DELTEC GRIPPER MICRO NEEDLE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• 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: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15066765
• Report Number: 3012307300-2022-13769
• Device Sequence Number: 5711910
• Product Code: FPA
• UDI-Device Identifier: 10610586029790
• UDI-Public: 10610586029790
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K072059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/20/2025
• Device Model Number: 21-3256-24
• Device Catalogue Number: 21-3256-24
• Device Lot Number: 4076628
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2022
• Supplement Date Received by Manufacturer: 11/18/2022
• Initial Report FDA Received Date: 07/20/2022
• Supplement Report FDA Received Date: 12/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2020
• 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